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Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005)

Primary Purpose

Bacterial Infections, Virus Diseases

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
V419
DAPTACEL™
PedvaxHIB™
Prevnar 13™
RotaTeq™
PENTACEL™
Recombivax HB vaccine
ActHIB™
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 or at 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, or any combination of the above
  • Participant has had a fever ≥38.0°C (≥110.4°F) within 24 hours of study enrollment
  • Participant was vaccinated with any non-study vaccine (i.e., inactivated, conjugated, live virus vaccine) within 30 days prior to study enrollment, except for inactivated influenza vaccine which will be permitted 15 days or more prior to enrollment
  • Participant 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 Type

    Experimental

    Active Comparator

    Arm Label

    V419

    Control

    Arm Description

    V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months 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, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months 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.

    Outcomes

    Primary 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 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 milli International units (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 International unit (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 Enzyme-linked Immunosorbent Assay (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. 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.
    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 <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 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 <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 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 <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.
    Geometric Mean Concentration of Antibodies to Pertussis Toxin
    Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin.
    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.

    Secondary 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 Immunoglobulin A (IgA) Antibodies to Rotavirus
    Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent assay for IgA antibodies to rotavirus.
    Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
    Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying abnormal, Somnolence, Decreased appetite, 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: Pyrexia, >=39.5°C (>=103.1°F) rectal; Vomiting, >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Decreased appetite, Refuses >=3 feeds or refuses most feeds; Irritability, Inconsolable.
    Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
    Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.
    Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
    Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.
    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.
    Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
    The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.
    Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
    The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.

    Full Information

    First Posted
    April 15, 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
    NCT01337167
    Brief Title
    Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005)
    Official Title
    A Phase III Randomized, Open-Label, Active-Comparator Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in 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
    April 19, 2011 (Actual)
    Primary Completion Date
    May 9, 2013 (Actual)
    Study Completion Date
    May 9, 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 is a study to assess the safety, tolerability, and immunogenicity of V419 (PR5I) when administered as an infant series at 2, 4, and 6 months of age followed by a toddler dose of DAPTACEL™, Prevnar 13™ and PedvaxHIB™ at 15 months of age. The study will determine whether subjects who receive V419 have a similar immune response to the vaccine compared to subjects who receive licensed component vaccine controls.

    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
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1473 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    V419
    Arm Type
    Experimental
    Arm Description
    V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months 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, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months 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.
    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) 0.5 mL intramuscular injection at 2, 4, and 6 months of age
    Intervention Type
    Biological
    Intervention Name(s)
    DAPTACEL™
    Intervention Description
    DAPTACEL™ 0.5 mL intramuscular injection at 15 months of age
    Intervention Type
    Biological
    Intervention Name(s)
    PedvaxHIB™
    Intervention Description
    PedvaxHIB™ 0.5 mL intramuscular injection at 15 months of age
    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™
    Other Intervention Name(s)
    V260
    Intervention Description
    RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age
    Intervention Type
    Biological
    Intervention Name(s)
    PENTACEL™
    Intervention Description
    PENTACEL™ 0.5 mL intramuscular injection 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
    Intervention Type
    Biological
    Intervention Name(s)
    ActHIB™
    Intervention Description
    ActHIB™ 0.5 mL intramuscular injection at 15 months of age
    Primary 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 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 milli International units (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 International unit (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 Enzyme-linked Immunosorbent Assay (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. 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
    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 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 <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 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 <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 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 <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 4 (Month 16)
    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.
    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.
    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.
    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.
    Time Frame
    Postdose 4 (Month 16)
    Secondary 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 Immunoglobulin A (IgA) Antibodies to Rotavirus
    Description
    Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent assay for IgA antibodies to rotavirus.
    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: Pyrexia, Vomiting, Crying abnormal, Somnolence, Decreased appetite, 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: Pyrexia, >=39.5°C (>=103.1°F) rectal; Vomiting, >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Decreased appetite, 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 Reporting One or More Solicited Adverse Events Related to Study Drug
    Description
    Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.
    Time Frame
    Up to 5 days after any infant vaccination (up to 6 months)
    Title
    Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
    Description
    Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.
    Time Frame
    Up to 5 days after each 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)
    Title
    Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
    Description
    The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.
    Time Frame
    Up to 15 days after any infant vaccination (up to 6 months)
    Title
    Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
    Description
    The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.
    Time Frame
    Up to 181 days after any infant vaccination (up to 12 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 or at 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, or any combination of the above Participant has had a fever ≥38.0°C (≥110.4°F) within 24 hours of study enrollment Participant was vaccinated with any non-study vaccine (i.e., inactivated, conjugated, live virus vaccine) within 30 days prior to study enrollment, except for inactivated influenza vaccine which will be permitted 15 days or more prior to enrollment Participant 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
    26216331
    Citation
    Marshall GS, Adams GL, Leonardi ML, Petrecz M, Flores SA, Ngai AL, Xu J, Liu G, Stek JE, Foglia G, Lee AW. Immunogenicity, Safety, and Tolerability of a Hexavalent Vaccine in Infants. Pediatrics. 2015 Aug;136(2):e323-32. doi: 10.1542/peds.2014-4102.
    Results Reference
    background

    Learn more about this trial

    Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005)

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