A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)
- Conditions
- Bacterial InfectionsVirus Diseases
- Interventions
- Biological: V419Biological: PENTACEL™Biological: Prevnar 13™Biological: RotaTeq™Biological: Recombivax HB vaccine
- Registration Number
- NCT01340937
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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™.
- Detailed 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2808
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description V419 Lot C Prevnar 13™ 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 Control Prevnar 13™ 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 V419 Lot A V419 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 V419 Lot A RotaTeq™ 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 Control RotaTeq™ 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 V419 Lot B V419 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 V419 Lot B PENTACEL™ 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 Control PENTACEL™ 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 V419 Lot B Prevnar 13™ 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 V419 Lot A PENTACEL™ 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 V419 Lot A Prevnar 13™ 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 V419 Lot B RotaTeq™ 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 V419 Lot C V419 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 V419 Lot C PENTACEL™ 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 V419 Lot C RotaTeq™ 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 Control Recombivax HB vaccine 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
- Primary Outcome Measures
Name Time Method Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen Postdose 3 (Month 7) Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.
Geometric Mean Concentration of Antibodies to Diphtheria Toxin Postdose 3 (Month 7) 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).
Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen Postdose 3 (Month 7) 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).
Geometric Mean Concentration of Antibodies to Pertussis Pertactin Postdose 3 (Month 7) Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.
Geometric Mean Titer for Antibodies to Poliovirus Type 1 Postdose 3 (Month 7) 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).
Geometric Mean Concentration of Antibodies to Pertussis Toxin Postdose 3 (Month 7) 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).
Geometric Mean Concentration of Antibodies to Tetanus Toxin Postdose 3 (Month 7) Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for anti-tetanus antibodies.
Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin Postdose 3 (Month 7) Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae Postdose 3 (Month 7) Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.
Geometric Mean Titer for Antibodies to Poliovirus Type 2 Postdose 3 (Month 7) Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2.
Geometric Mean Titer for Antibodies to Poliovirus Type 3 Postdose 3 (Month 7) Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen Postdose 3 (Month 7) Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for a titer \>=0.15 µg/mL and \>=1.0 µg/mL.
Percentage of Participants Responding to Tetanus Toxin Postdose 3 (Month 7) Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer \>=0.1 IU/mL.
Percentage of Participants Responding to Poliovirus Type 1 Postdose 3 (Month 7) Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer \>=8.
Percentage of Participants Responding to Poliovirus Type 2 Postdose 3 (Month 7) Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. Response is defined as a titer \>=8.
Geometric Mean Concentration of Antibodies to Pertussis Toxin Postdose 4 (Month 16) Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae Postdose 4 (Month 16) Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
Percentage of Participants Responding to Diphtheria Toxin Postdose 3 (Month 7) Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer \>=0.1 IU/mL.
Percentage of Participants Responding to Pertussis Toxin Postdose 4 (Month 16) Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was \<4X LLOQ then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
Percentage of Participants Responding to Pertussis Fimbriae Postdose 4 (Month 16) Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was \<4X LLOQ then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin Postdose 4 (Month 16) Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Up to 5 days after any infant vaccination (up to 6 months) Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reaction: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, \>5 cm. Grade 3 Solicited systemic reactions: Fever (Pyrexia), \>=39.5°C rectal; Vomiting, \>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, \>3 hours; Drowsiness (Somnolence), Sleeping most of the time or difficult to wake up; Appetite lost, Refuses \>=3 feeds or refuses most feeds; Irritability, Inconsolable.
Geometric Mean Concentration of Antibodies to Pertussis Pertactin Postdose 4 (Month 16) Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Postdose 3 (Month 7) Participant serum samples were collected for testing with a multiplex electrochemiluminescence-based detection assay for serotype-specific pneumococcal polysaccharide antibodies. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
Percentage of Participants With Elevated Temperature by Severity Up to 5 days after any infant vaccination (up to 6 months) Maximum temperature (all routes) was based on actual temperatures recorded with no adjustments to the measurement route. Maximum temperature (rectal) was required of all participants if the reading by another method was \>=38.0°C.
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin Postdose 4 (Month 16) Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was \<4X LLOQ then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
Percentage of Participants Responding to Hepatitis B Surface Antigen Postdose 3 (Month 7) Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer \>=10 mIU/mL.
Percentage of Participants Responding to Pertussis Pertactin Postdose 4 (Month 16) Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was \<4X LLOQ then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
Percentage of Participants Responding to Poliovirus Type 3 Postdose 3 (Month 7) Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. Response is defined as a titer \>=8.