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A Study of the Safety and Tolerability of V419 in Healthy Infants at 2,4, 6 and 12 to 14 Months of Age (V419-003)

Primary Purpose

Bacterial Infections; Virus Diseases

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

AR51 (12, 10)

PR51 (3, 10)

PR51 (6, 10)

PENTACEL™

RECOMBIVAX HB™

About this trial

This is an interventional prevention trial for Bacterial Infections; Virus Diseases

Eligibility Criteria

6 Weeks - 9 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy infants 2 months of age who have not received prior vaccinations for Haemophilus influenzae type b (Hib), hepatitis B, Diptheria/Pertussis/Tetanus (DPT), or Polio

Exclusion Criteria:

HIV infection in participant (child/mother)
Documented HBsAg seropositivity in the participant (child or mother)
History of invasive Hib disease, hepatitis B, diphtheria, tetanus, pertussis, or poliovirus infection
History of seizure disorder
Underlying medical conditions such as inborn errors of metabolism, failure to thrive, or any major congenital abnormalities requiring surgery
Prior or anticipated receipt of immune globulin, blood, or blood products
Known hypersensitivity to any component of the investigational or marketed vaccines being administered in this protocol
Any history or condition that would exclude the participant from receiving any vaccine administered under this protocol based on the contraindications that appear in the package circulars for each component of these vaccines
Any condition that, in the opinion of the investigator, is not stable or may interfere with the evaluation of the study objectives

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

AR51 (12, 10)

PR51 (3, 10)

PR51 (6, 10)

PENTACEL™ + RECOMBIVAX HB™

Arm Description

Participants were vaccinated with 0.5 ml of AR51 (12,10) formulation via intramuscular injection as a primary series at 2, 4, and 6 months of age, and as a booster at 12 to 14 months of age.

Participants were vaccinated with 0.5 ml of PR51 (3,10) formulation via intramuscular injection as a primary series at 2, 4, and 6 months of age, and as a booster at 12 to 14 months of age.

Participants were vaccinated with 0.5 ml of PR51 (6,10) formulation via intramuscular injection as a primary series at 2, 4, and 6 months of age, and as a booster at 12 to 14 months of age.

Participants were vaccinated with 0.5 ml each of PENTACEL™ + RECOMBIVAX HB™ via intramuscular injection as a primary series at 2, 4, and 6 months of age, and with 0.5 ml PENTACEL™ as a booster at 12 to 14 months of age.

Outcomes

Primary Outcome Measures

Percentage of participants with level of anti-PRP antibodies >1.0 μg/mL at the Postdose 3 time point

Percentage of participants with level of anti-HBsAg antibodies ≥10 mIU/L at the Postdose 3 time point

Percentage of participants with a ≥4-fold rise in levels of antibodies to pertussis antigens at the Postdose 3 time point

Percentage of participants with level of anti-diphtheria antibodies ≥0.01 IU/mL at the Postdose 3 time point

Percentage of participants with level of anti-tetanus antibodies ≥0.01 IU/mL at the Postdose 3 time point

Percentage of participants with neutralizing anti-poliovirus type antibodies at ≥1:8 dilution at the Postdose 3 time point

Secondary Outcome Measures

Percentage of participants with level of anti-PRP antibodies >1.0 μg/mL at the Postdose 2 time point

Percentage of participants with level of anti-HBsAg antibodies ≥10 mIU/L at the Postdose 2 time point

Percentage of participants with a ≥4-fold rise in level of antibodies to pertussis antigens at the Postdose 2 time point

Percentage of participants with level of anti-diphtheria antibodies ≥0.01 IU/mL at the Postdose 2 time point

Percentage of participants with level of anti-tetanus antibodies ≥0.01 IU/mL at the Postdose 2 time point

Percentage of participants with neutralizing anti-poliovirus type antibodies at ≥1:8 dilution at the Postdose 2 time point

Number of participants with at least 1 adverse event (AE)

Number of participants who discontinued study treatment due to an AE

Full Information

NCT ID

NCT00551915

First Posted

October 29, 2007

Last Updated

October 29, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00551915

Brief Title

A Study of the Safety and Tolerability of V419 in Healthy Infants at 2,4, 6 and 12 to 14 Months of Age (V419-003)

Official Title

Safety, Tolerability, and Immunogenicity of 3 Different Formulations of a Liquid Hexavalent Combination Vaccine, HR5I When Administered to Healthy Hepatitis B Vaccine-Naive Infants at 2, 4, 6, and 12-14 Months of Age

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

May 2001 (undefined)

Primary Completion Date

January 2003 (Actual)

Study Completion Date

January 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of 3 formulations of the HR5I vaccine (Haemophilus influenzae type b conjugate, recombinant hepatitis B surface antigen, diphtheria, tetanus, 5-component acellular pertussis, and inactivated poliovirus Types 1, 2, and 3). The primary hypothesis is that at least 1 of the 3 formulations of HR5I administered as a primary series at 2, 4, and 6 months of age will be acceptable (similar to targeted rates) with respect to Postdose 3 antibody responses to all antigens.

Detailed Description

Participants will be randomized into 4 arms: AR51 (12, 10): arm receiving vaccine formulation containing 12 mcg of polyribosylribitol phosphate (PRP) conjugated to tetanus toxoid (PRP-T) and 10 mcg of Hepatitis B surface antigen (HBsAg) PR51 (3, 10): arm receiving vaccine formulation containing 3 mcg of polyribosylribitol phosphate conjugated to the outer membrane protein complex of Neisseria meningitides (PRP-OMPC) and 10 mcg of HBsAg PR51 (6, 10): arm receiving vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg PENTACEL™ + RECOMBIVAX HB™: open-label control group receiving PENTACEL™ (licensed vaccine for diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b) and RECOMBIVAX HB™ (licensed vaccine for hepatitis)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacterial Infections; Virus Diseases

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

756 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AR51 (12, 10)

Arm Type

Experimental

Arm Description

Participants were vaccinated with 0.5 ml of AR51 (12,10) formulation via intramuscular injection as a primary series at 2, 4, and 6 months of age, and as a booster at 12 to 14 months of age.

Arm Title

PR51 (3, 10)

Arm Type

Experimental

Arm Description

Participants were vaccinated with 0.5 ml of PR51 (3,10) formulation via intramuscular injection as a primary series at 2, 4, and 6 months of age, and as a booster at 12 to 14 months of age.

Arm Title

PR51 (6, 10)

Arm Type

Experimental

Arm Description

Participants were vaccinated with 0.5 ml of PR51 (6,10) formulation via intramuscular injection as a primary series at 2, 4, and 6 months of age, and as a booster at 12 to 14 months of age.

Arm Title

PENTACEL™ + RECOMBIVAX HB™

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

AR51 (12, 10)

Intervention Description

vaccine formulation containing 12 mcg of PRP-T and 10 mcg of HBsAg

Intervention Type

Biological

Intervention Name(s)

PR51 (3, 10)

Intervention Description

vaccine formulation containing 3 mcg of PRP-OMPC and 10 mcg of HBsAg

Intervention Type

Biological

Intervention Name(s)

PR51 (6, 10)

Intervention Description

vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg

Intervention Type

Biological

Intervention Name(s)

PENTACEL™

Intervention Description

licensed vaccine for diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b, administered open-label

Intervention Type

Biological

Intervention Name(s)

RECOMBIVAX HB™

Intervention Description

licensed vaccine for hepatitis, administered open-label

Primary Outcome Measure Information:

Title

Percentage of participants with level of anti-PRP antibodies >1.0 μg/mL at the Postdose 3 time point

Time Frame