Clinical trial NCT01337167: Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005)
Official title: A Phase III Randomized, Open-Label, Active-Comparator Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Infants When Given at 2, 4, and 6 Months Concomitantly With Prevnar 13™ and RotaTeq™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Infections
Virus Diseases
Keywords: Diphtheria
Tetanus
Whooping Cough (pertussis)
Poliomyelitis
Hepatitis B infection
Haemophilus influenzae type b infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: MCM Vaccines B.V.
First posted: 2011-04-18
Enrollment: 1473
Sex: ALL
Minimum age (years): 46
Maximum age (years): 89
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen
timeFrame: Postdose 3 (Month 7)
measure: Percentage of Participants Responding to Hepatitis B Surface Antigen
timeFrame: Postdose 3 (Month 7)
measure: Percentage of Participants Responding to Diphtheria Toxin
timeFrame: Postdose 3 (Month 7)
measure: Percentage of Participants Responding to Tetanus Toxin
timeFrame: Postdose 3 (Month 7)
measure: Percentage of Participants Responding to Pertussis Toxin
timeFrame: Postdose 3 (Month 7)
measure: Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
timeFrame: Postdose 3 (Month 7)
measure: Percentage of Participants Responding to Pertussis Pertactin
timeFrame: Postdose 3 (Month 7)
measure: Percentage of Participants Responding to Pertussis Fimbriae
timeFrame: Postdose 3 (Month 7)
measure: Percentage of Participants Responding to Poliovirus Type 1
timeFrame: Postdose 3 (Month 7)
measure: Percentage of Participants Responding to Poliovirus Type 2
timeFrame: Postdose 3 (Month 7)
measure: Percentage of Participants Responding to Poliovirus Type 3
timeFrame: Postdose 3 (Month 7)
measure: Geometric Mean Concentration of Antibodies to Pertussis Toxin
timeFrame: Postdose 3 (Month 7)
measure: Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin
timeFrame: Postdose 3 (Month 7)
measure: Geometric Mean Concentration of Antibodies to Pertussis Pertactin
timeFrame: Postdose 3 (Month 7)
measure: Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
timeFrame: Postdose 3 (Month 7)
measure: Percentage of Participants Responding to Pertussis Toxin
timeFrame: Postdose 4 (Month 16)
measure: Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
timeFrame: Postdose 4 (Month 16)
measure: Percentage of Participants Responding to Pertussis Pertactin
timeFrame: Postdose 4 (Month 16)
measure: Percentage of Participants Responding to Pertussis Fimbriae
timeFrame: Postdose 4 (Month 16)
measure: Geometric Mean Concentration of Antibodies to Pertussis Toxin
timeFrame: Postdose 4 (Month 16)
measure: Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin
timeFrame: Postdose 4 (Month 16)
measure: Geometric Mean Concentration of Antibodies to Pertussis Pertactin
timeFrame: Postdose 4 (Month 16)
measure: Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
timeFrame: Postdose 4 (Month 16)
Secondary outcomes:
measure: Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen
timeFrame: Postdose 3 (Month 7)
measure: Geometric Mean Concentration of Immunoglobulin A (IgA) Antibodies to Rotavirus
timeFrame: Postdose 3 (Month 7)
measure: Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
timeFrame: Up to 5 days after any infant vaccination (up to 6 months)
measure: Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
timeFrame: Up to 5 days after any infant vaccination (up to 6 months)
measure: Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
timeFrame: Up to 5 days after each infant vaccination (up to 6 months)
measure: Percentage of Participants With Elevated Temperature by Severity
timeFrame: Up to 5 days after any infant vaccination (up to 6 months)
measure: Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
timeFrame: Up to 15 days after any infant vaccination (up to 6 months)
measure: Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
timeFrame: Up to 181 days after any infant vaccination (up to 12 months)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Marshall GS, Adams GL, Leonardi ML, Petrecz M, Flores SA, Ngai AL, Xu J, Liu G, Stek JE, Foglia G, Lee AW. Immunogenicity, Safety, and Tolerability of a Hexavalent Vaccine in Infants. Pediatrics. 2015 Aug;136(2):e323-32. doi: 10.1542/peds.2014-4102.