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

NCT01340937 | Completed Phase 3 Results

• 1 other identifier: V419-006
• Study Type: interventional
• Target: 2,808
• Locations: 0 countries
• Sites: N/A

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™.

Conditions

Bacterial Infections; Virus Diseases

Keywords

Diphtheria; Tetanus; Whooping Cough (pertussis); Poliomyelitis; Hepatitis B infection; Haemophilus influenzae type b infection

Outcome Measures

Primary Outcomes (11)

• 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.

  Postdose 3 (Month 7)

• 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).

  Postdose 3 (Month 7)

• 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).

  Postdose 3 (Month 7)

• 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.

  Postdose 3 (Month 7)

• 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).

  Postdose 3 (Month 7)

• 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.

  Postdose 3 (Month 7)

• Geometric Mean Concentration of Antibodies to Pertussis Pertactin

  Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.

  Postdose 3 (Month 7)

• Geometric Mean Concentration of Antibodies to Pertussis Fimbriae

  Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.

  Postdose 3 (Month 7)

• 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).

  Postdose 3 (Month 7)

• 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.

  Postdose 3 (Month 7)

• 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.

  Postdose 3 (Month 7)

Secondary Outcomes (22)

• Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen

  Postdose 3 (Month 7)

• Percentage of Participants Responding to Hepatitis B Surface Antigen

  Postdose 3 (Month 7)

• Percentage of Participants Responding to Diphtheria Toxin

  Postdose 3 (Month 7)

• Percentage of Participants Responding to Tetanus Toxin

  Postdose 3 (Month 7)

• Percentage of Participants Responding to Pertussis Toxin

  Postdose 3 (Month 7)

Study Arms (4)

V419 Lot A

EXPERIMENTAL

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

Biological: V419; Biological: PENTACEL™; Biological: Prevnar 13™; Biological: RotaTeq™

V419 Lot B

EXPERIMENTAL

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

Biological: V419; Biological: PENTACEL™; Biological: Prevnar 13™; Biological: RotaTeq™

V419 Lot C

EXPERIMENTAL

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

Biological: V419; Biological: PENTACEL™; Biological: Prevnar 13™; Biological: RotaTeq™

Control

ACTIVE COMPARATOR

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

Biological: PENTACEL™; Biological: Prevnar 13™; Biological: RotaTeq™; Biological: Recombivax HB vaccine

Interventions

V419 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.

V419 Lot A; V419 Lot B; V419 Lot C

PENTACEL™ 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

Control; V419 Lot A; V419 Lot B; V419 Lot C

Prevnar 13™ BIOLOGICAL

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

Control; V419 Lot A; V419 Lot B; V419 Lot C

RotaTeq™ BIOLOGICAL

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

Control; V419 Lot A; V419 Lot B; V419 Lot C

Recombivax HB vaccine BIOLOGICAL

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

Control

Eligibility Criteria

• Age: 46 Days - 89 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• MCM Vaccines B.V.: collaborator

Related Publications (1)

• 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.

  PMID: 27846058 RESULT

MeSH Terms

Conditions

Bacterial Infections; Virus Diseases; Diphtheria; Tetanus; Whooping Cough; Poliomyelitis; Hepatitis B; Haemophilus Infections

Interventions

pentacel; 13-valent pneumococcal vaccine; RotaTeq

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Pasteurellaceae Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: April 25, 2011
• Study Start: May 10, 2011
• Primary Completion: December 18, 2012
• Study Completion: July 26, 2013
• Last Updated: November 15, 2018
• Results First Posted: May 2, 2016

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share