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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Virus Diseases; Bacterial Infections

Treatments: Biological: PedvaxHIB™; Biological: PENTACEL™; Biological: ActHIB™; Biological: Prevnar 13™; Biological: V419; Biological: DAPTACEL™; Biological: Recombivax HB vaccine; Biological: RotaTeq™

Study type: Interventional

Funder types: Industry

Identifiers

NCT01337167

V419-005

Details and patient eligibility

About

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.

Enrollment: 1,473 patients

Sex: All

Ages: 46 to 89 days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,473 participants in 2 patient groups

V419

Experimental group

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.

Treatment:

Biological: RotaTeq™

Biological: PedvaxHIB™

Biological: DAPTACEL™

Biological: V419

Biological: Prevnar 13™

Control

Active Comparator group

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.

Treatment:

Biological: RotaTeq™

Biological: Recombivax HB vaccine

Biological: DAPTACEL™

Biological: PENTACEL™

Biological: Prevnar 13™

Biological: ActHIB™