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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Virus Diseases; Bacterial Infections

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01340937

V419-006

Details and patient eligibility

About

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™.

Full description

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).

Enrollment: 2,808 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 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,808 participants in 4 patient groups

V419 Lot A

Experimental group

Description:

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

Treatment:

Biological: V419

Biological: RotaTeq™

Biological: PENTACEL™

Biological: Prevnar 13™

V419 Lot B

Experimental group

Description:

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

Treatment:

Biological: V419

Biological: RotaTeq™

Biological: PENTACEL™

Biological: Prevnar 13™

V419 Lot C

Experimental group

Description:

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

Treatment:

Biological: V419

Biological: RotaTeq™

Biological: PENTACEL™

Biological: Prevnar 13™

Control

Active Comparator group

Description:

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

Treatment:

Biological: RotaTeq™

Biological: PENTACEL™

Biological: Recombivax HB vaccine

Biological: Prevnar 13™