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A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)

Primary Purpose

Bacterial Infections, Virus Diseases

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
V419
PENTACEL™
Prevnar 13™
RotaTeq™
Recombivax HB vaccine
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacterial Infections focused on measuring Diphtheria, Tetanus, Whooping Cough (pertussis), Poliomyelitis, Hepatitis B infection, Haemophilus influenzae type b infection

Eligibility Criteria

46 Days - 89 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria :

  • Participant is a healthy infant
  • Participant has received one dose of monovalent hepatitis B vaccine prior to 1 month of age

Exclusion Criteria :

  • Participant has received more than one dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry
  • Participant has been vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, measles, mumps, rubella, or varicella vaccines or any combination of the above
  • Participant has had an illness with fever within 24 hours of study enrollment
  • Participant was vaccinated with any non-study vaccine (i.e. inactivated, conjugated or live virus vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 15 days or more prior to enrollment
  • Participant or his/her mother has hepatitis B surface antigen (HBsAg) seropositivity (by medical history)
  • Participant has a history of haemophilus influenzae type B, hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus, or pneumococcal infection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    V419 Lot A

    V419 Lot B

    V419 Lot C

    Control

    Arm Description

    V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age

    V419 (Lot B) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age

    V419 (Lot C) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age

    Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age

    Outcomes

    Primary Outcome Measures

    Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen
    Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.
    Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen
    Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. The unit of measure is milli International Units/mL (mIU/mL).
    Geometric Mean Concentration of Antibodies to Diphtheria Toxin
    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. The unit of measure is International Units/mL (IU/mL).
    Geometric Mean Concentration of Antibodies to Tetanus Toxin
    Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for anti-tetanus antibodies.
    Geometric Mean Concentration of Antibodies to Pertussis Toxin
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL).
    Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.
    Geometric Mean Concentration of Antibodies to Pertussis Pertactin
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.
    Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.
    Geometric Mean Titer for Antibodies to Poliovirus Type 1
    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. The unit of measure is titer (reciprocal of highest dilution with neutralizing activity).
    Geometric Mean Titer for Antibodies to Poliovirus Type 2
    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2.
    Geometric Mean Titer for Antibodies to Poliovirus Type 3
    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3.

    Secondary Outcome Measures

    Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen
    Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for a titer >=0.15 µg/mL and >=1.0 µg/mL.
    Percentage of Participants Responding to Hepatitis B Surface Antigen
    Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer >=10 mIU/mL.
    Percentage of Participants Responding to Diphtheria Toxin
    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer >=0.1 IU/mL.
    Percentage of Participants Responding to Tetanus Toxin
    Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer >=0.1 IU/mL.
    Percentage of Participants Responding to Pertussis Toxin
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.
    Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.
    Percentage of Participants Responding to Pertussis Pertactin
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.
    Percentage of Participants Responding to Pertussis Fimbriae
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.
    Percentage of Participants Responding to Poliovirus Type 1
    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer >=8.
    Percentage of Participants Responding to Poliovirus Type 2
    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. Response is defined as a titer >=8.
    Percentage of Participants Responding to Poliovirus Type 3
    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. Response is defined as a titer >=8.
    Geometric Mean Concentration of Antibodies to Pertussis Toxin
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
    Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
    Geometric Mean Concentration of Antibodies to Pertussis Pertactin
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
    Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
    Percentage of Participants Responding to Pertussis Toxin
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
    Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
    Percentage of Participants Responding to Pertussis Pertactin
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
    Percentage of Participants Responding to Pertussis Fimbriae
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
    Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes
    Participant serum samples were collected for testing with a multiplex electrochemiluminescence-based detection assay for serotype-specific pneumococcal polysaccharide antibodies. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
    Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reaction: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, >5 cm. Grade 3 Solicited systemic reactions: Fever (Pyrexia), >=39.5°C rectal; Vomiting, >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness (Somnolence), Sleeping most of the time or difficult to wake up; Appetite lost, Refuses >=3 feeds or refuses most feeds; Irritability, Inconsolable.
    Percentage of Participants With Elevated Temperature by Severity
    Maximum temperature (all routes) was based on actual temperatures recorded with no adjustments to the measurement route. Maximum temperature (rectal) was required of all participants if the reading by another method was >=38.0°C.

    Full Information

    First Posted
    April 21, 2011
    Last Updated
    October 19, 2018
    Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    MCM Vaccines B.V.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01340937
    Brief Title
    A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)
    Official Title
    A Phase III Randomized, Partially Double-Blind, Active-Comparator-Controlled, Lot-to-Lot Consistency Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 6 Months Concomitantly With Prevnar 13™ and RotaTeq ™
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 10, 2011 (Actual)
    Primary Completion Date
    December 18, 2012 (Actual)
    Study Completion Date
    July 26, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    MCM Vaccines B.V.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will determine whether three manufacturing lots of V419 (PR5I) induce similar immune responses to all of the antigens contained in V419 when given concomitantly with Prevnar13™ and RotaTeq™.
    Detailed Description
    This study is partially Double-Blinded in that the participants' parents/guardians, investigator/study site personnel, and Sponsor's representatives will be blinded to the lot of V419 the participant is randomized to receive, but not to the participant's treatment group (V419 or control).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bacterial Infections, Virus Diseases
    Keywords
    Diphtheria, Tetanus, Whooping Cough (pertussis), Poliomyelitis, Hepatitis B infection, Haemophilus influenzae type b infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    2808 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    V419 Lot A
    Arm Type
    Experimental
    Arm Description
    V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age
    Arm Title
    V419 Lot B
    Arm Type
    Experimental
    Arm Description
    V419 (Lot B) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age
    Arm Title
    V419 Lot C
    Arm Type
    Experimental
    Arm Description
    V419 (Lot C) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age
    Intervention Type
    Biological
    Intervention Name(s)
    V419
    Intervention Description
    V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Outer Membrane Protein Complex], and Hepatitis B [Recombinant] Vaccine) (from one of three lots) 0.5 mL intramuscular injection at 2, 4, and 6 months of age.
    Intervention Type
    Biological
    Intervention Name(s)
    PENTACEL™
    Intervention Description
    PENTACEL™ 0.5 mL intramuscular injection at 15 months of age in the V419 groups and at 2, 4, 6, and 15 months of age in the control group
    Intervention Type
    Biological
    Intervention Name(s)
    Prevnar 13™
    Intervention Description
    Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age
    Intervention Type
    Biological
    Intervention Name(s)
    RotaTeq™
    Intervention Description
    RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age
    Intervention Type
    Biological
    Intervention Name(s)
    Recombivax HB vaccine
    Intervention Description
    Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age
    Primary Outcome Measure Information:
    Title
    Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen
    Description
    Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.
    Time Frame
    Postdose 3 (Month 7)
    Title
    Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen
    Description
    Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. The unit of measure is milli International Units/mL (mIU/mL).
    Time Frame
    Postdose 3 (Month 7)
    Title
    Geometric Mean Concentration of Antibodies to Diphtheria Toxin
    Description
    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. The unit of measure is International Units/mL (IU/mL).
    Time Frame
    Postdose 3 (Month 7)
    Title
    Geometric Mean Concentration of Antibodies to Tetanus Toxin
    Description
    Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for anti-tetanus antibodies.
    Time Frame
    Postdose 3 (Month 7)
    Title
    Geometric Mean Concentration of Antibodies to Pertussis Toxin
    Description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL).
    Time Frame
    Postdose 3 (Month 7)
    Title
    Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin
    Description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.
    Time Frame
    Postdose 3 (Month 7)
    Title
    Geometric Mean Concentration of Antibodies to Pertussis Pertactin
    Description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.
    Time Frame
    Postdose 3 (Month 7)
    Title
    Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
    Description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.
    Time Frame
    Postdose 3 (Month 7)
    Title
    Geometric Mean Titer for Antibodies to Poliovirus Type 1
    Description
    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. The unit of measure is titer (reciprocal of highest dilution with neutralizing activity).
    Time Frame
    Postdose 3 (Month 7)
    Title
    Geometric Mean Titer for Antibodies to Poliovirus Type 2
    Description
    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2.
    Time Frame
    Postdose 3 (Month 7)
    Title
    Geometric Mean Titer for Antibodies to Poliovirus Type 3
    Description
    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3.
    Time Frame
    Postdose 3 (Month 7)
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen
    Description
    Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for a titer >=0.15 µg/mL and >=1.0 µg/mL.
    Time Frame
    Postdose 3 (Month 7)
    Title
    Percentage of Participants Responding to Hepatitis B Surface Antigen
    Description
    Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer >=10 mIU/mL.
    Time Frame
    Postdose 3 (Month 7)
    Title
    Percentage of Participants Responding to Diphtheria Toxin
    Description
    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer >=0.1 IU/mL.
    Time Frame
    Postdose 3 (Month 7)
    Title
    Percentage of Participants Responding to Tetanus Toxin
    Description
    Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer >=0.1 IU/mL.
    Time Frame
    Postdose 3 (Month 7)
    Title
    Percentage of Participants Responding to Pertussis Toxin
    Description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.
    Time Frame
    Postdose 3 (Month 7)
    Title
    Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
    Description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.
    Time Frame
    Postdose 3 (Month 7)
    Title
    Percentage of Participants Responding to Pertussis Pertactin
    Description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.
    Time Frame
    Postdose 3 (Month 7)
    Title
    Percentage of Participants Responding to Pertussis Fimbriae
    Description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.
    Time Frame
    Postdose 3 (Month 7)
    Title
    Percentage of Participants Responding to Poliovirus Type 1
    Description
    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer >=8.
    Time Frame
    Postdose 3 (Month 7)
    Title
    Percentage of Participants Responding to Poliovirus Type 2
    Description
    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. Response is defined as a titer >=8.
    Time Frame
    Postdose 3 (Month 7)
    Title
    Percentage of Participants Responding to Poliovirus Type 3
    Description
    Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. Response is defined as a titer >=8.
    Time Frame
    Postdose 3 (Month 7)
    Title
    Geometric Mean Concentration of Antibodies to Pertussis Toxin
    Description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
    Time Frame
    Postdose 4 (Month 16)
    Title
    Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin
    Description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
    Time Frame
    Postdose 4 (Month 16)
    Title
    Geometric Mean Concentration of Antibodies to Pertussis Pertactin
    Description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
    Time Frame
    Postdose 4 (Month 16)
    Title
    Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
    Description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
    Time Frame
    Postdose 4 (Month 16)
    Title
    Percentage of Participants Responding to Pertussis Toxin
    Description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
    Time Frame
    Postdose 4 (Month 16)
    Title
    Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
    Description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
    Time Frame
    Postdose 4 (Month 16)
    Title
    Percentage of Participants Responding to Pertussis Pertactin
    Description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
    Time Frame
    Postdose 4 (Month 16)
    Title
    Percentage of Participants Responding to Pertussis Fimbriae
    Description
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
    Time Frame
    Postdose 4 (Month 16)
    Title
    Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes
    Description
    Participant serum samples were collected for testing with a multiplex electrochemiluminescence-based detection assay for serotype-specific pneumococcal polysaccharide antibodies. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
    Time Frame
    Postdose 3 (Month 7)
    Title
    Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
    Description
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reaction: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, >5 cm. Grade 3 Solicited systemic reactions: Fever (Pyrexia), >=39.5°C rectal; Vomiting, >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness (Somnolence), Sleeping most of the time or difficult to wake up; Appetite lost, Refuses >=3 feeds or refuses most feeds; Irritability, Inconsolable.
    Time Frame
    Up to 5 days after any infant vaccination (up to 6 months)
    Title
    Percentage of Participants With Elevated Temperature by Severity
    Description
    Maximum temperature (all routes) was based on actual temperatures recorded with no adjustments to the measurement route. Maximum temperature (rectal) was required of all participants if the reading by another method was >=38.0°C.
    Time Frame
    Up to 5 days after any infant vaccination (up to 6 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    46 Days
    Maximum Age & Unit of Time
    89 Days
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria : Participant is a healthy infant Participant has received one dose of monovalent hepatitis B vaccine prior to 1 month of age Exclusion Criteria : Participant has received more than one dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry Participant has been vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, measles, mumps, rubella, or varicella vaccines or any combination of the above Participant has had an illness with fever within 24 hours of study enrollment Participant was vaccinated with any non-study vaccine (i.e. inactivated, conjugated or live virus vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 15 days or more prior to enrollment Participant or his/her mother has hepatitis B surface antigen (HBsAg) seropositivity (by medical history) Participant has a history of haemophilus influenzae type B, hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus, or pneumococcal infection
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    27846058
    Citation
    Block SL, Klein NP, Sarpong K, Russell S, Fling J, Petrecz M, Flores S, Xu J, Liu G, Stek JE, Foglia G, Lee AW. Lot-to-lot Consistency, Safety, Tolerability and Immunogenicity of an Investigational Hexavalent Vaccine in US Infants. Pediatr Infect Dis J. 2017 Feb;36(2):202-208. doi: 10.1097/INF.0000000000001405.
    Results Reference
    result

    Learn more about this trial

    A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)

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