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

NCT ID: NCT01340937

Last Updated: 2018-11-15

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2808 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-10

Study Completion Date

2013-07-26

Brief Summary

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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™.

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Detailed Description

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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).

Conditions

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Bacterial Infections Virus Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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V419 Lot A

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

Group Type EXPERIMENTAL

V419

Intervention Type BIOLOGICAL

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.

PENTACEL™

Intervention Type BIOLOGICAL

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

Prevnar 13™

Intervention Type BIOLOGICAL

Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age

RotaTeq™

Intervention Type BIOLOGICAL

RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age

V419 Lot B

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

Group Type EXPERIMENTAL

V419

Intervention Type BIOLOGICAL

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.

PENTACEL™

Intervention Type BIOLOGICAL

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

Prevnar 13™

Intervention Type BIOLOGICAL

Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age

RotaTeq™

Intervention Type BIOLOGICAL

RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age

V419 Lot C

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

Group Type EXPERIMENTAL

V419

Intervention Type BIOLOGICAL

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.

PENTACEL™

Intervention Type BIOLOGICAL

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

Prevnar 13™

Intervention Type BIOLOGICAL

Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age

RotaTeq™

Intervention Type BIOLOGICAL

RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age

Control

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

Group Type ACTIVE_COMPARATOR

PENTACEL™

Intervention Type BIOLOGICAL

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

Prevnar 13™

Intervention Type BIOLOGICAL

Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age

RotaTeq™

Intervention Type BIOLOGICAL

RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age

Recombivax HB vaccine

Intervention Type BIOLOGICAL

Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age

Interventions

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V419

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

PENTACEL™

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

Prevnar 13™

Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age

Intervention Type BIOLOGICAL

RotaTeq™

RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age

Intervention Type BIOLOGICAL

Recombivax HB vaccine

Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

46 Days

Maximum Eligible Age

89 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MCM Vaccines B.V.

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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.

Reference Type RESULT
PMID: 27846058 (View on PubMed)

Other Identifiers

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V419-006

Identifier Type: -

Identifier Source: org_study_id

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