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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,473
V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate \[Meningococcal Outer Membrane Protein Complex\], and Hepatitis B \[Recombinant\] Vaccine) 0.5 mL intramuscular injection at 2, 4, and 6 months of age
DAPTACEL™ 0.5 mL intramuscular injection at 15 months of age
PedvaxHIB™ 0.5 mL intramuscular injection at 15 months of age
Percentage of Participants Responding 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. Response was evaluated for titer \>=0.15 μg/mL and \>=1.0 μg/mL.
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Hepatitis B Surface Antigen
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 milli International units (mIU)/mL.
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Diphtheria Toxin
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 International unit (IU)/mL.
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Tetanus Toxin
Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer \>=0.1 IU/mL.
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Pertussis Toxin
Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was \<4 times the lower limit of quantitation (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.
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
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Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age
RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age
PENTACEL™ 0.5 mL intramuscular injection at 2, 4, and 6 months of age
Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age
ActHIB™ 0.5 mL intramuscular injection at 15 months of age
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.
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Pertussis Pertactin
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.
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Pertussis Fimbriae
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.
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Poliovirus Type 1
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.
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Poliovirus Type 2
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.
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Poliovirus Type 3
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Pertussis Toxin
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 \<4 times the lower limit of quantitation (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.
Time frame: Postdose 4 (Month 16)
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
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 \<4 times the lower limit of quantitation (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.
Time frame: Postdose 4 (Month 16)
Percentage of Participants Responding to Pertussis Pertactin
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 \<4 times the lower limit of quantitation (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.
Time frame: Postdose 4 (Month 16)
Percentage of Participants Responding to Pertussis Fimbriae
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 \<4 times the lower limit of quantitation (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.
Time frame: Postdose 4 (Month 16)
Geometric Mean Concentration of Antibodies to Pertussis Toxin
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin.
Time frame: Postdose 4 (Month 16)
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.
Time frame: Postdose 4 (Month 16)
Geometric Mean Concentration of Antibodies to Pertussis Pertactin
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.
Time frame: Postdose 4 (Month 16)
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.
Time frame: Postdose 4 (Month 16)
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.
Time frame: Postdose 3 (Month 7)
Geometric Mean Concentration of Immunoglobulin A (IgA) Antibodies to Rotavirus
Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent assay for IgA antibodies to rotavirus.
Time frame: Postdose 3 (Month 7)
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying abnormal, Somnolence, Decreased appetite, 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: Pyrexia, \>=39.5°C (\>=103.1°F) rectal; Vomiting, \>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, \>3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Decreased appetite, Refuses \>=3 feeds or refuses most feeds; Irritability, Inconsolable.
Time frame: Up to 5 days after any infant vaccination (up to 6 months)
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.
Time frame: Up to 5 days after any infant vaccination (up to 6 months)
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.
Time frame: Up to 5 days after each infant vaccination (up to 6 months)
Percentage of Participants With Elevated Temperature by Severity
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.
Time frame: Up to 5 days after any infant vaccination (up to 6 months)
Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.
Time frame: Up to 15 days after any infant vaccination (up to 6 months)
Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.
Time frame: Up to 181 days after any infant vaccination (up to 12 months)