Clinical trial NCT01340937: A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)
Official title: A Phase III Randomized, Partially Double-Blind, Active-Comparator-Controlled, Lot-to-Lot Consistency Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Healthy 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: 2011-04-25
Enrollment: 2808
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 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).

Eligibility 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

Primary outcomes:
measure: Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen
timeFrame: Postdose 3 (Month 7)
measure: Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen
timeFrame: Postdose 3 (Month 7)
measure: Geometric Mean Concentration of Antibodies to Diphtheria Toxin
timeFrame: Postdose 3 (Month 7)
measure: Geometric Mean Concentration of Antibodies to Tetanus Toxin
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: Geometric Mean Titer for Antibodies to Poliovirus Type 1
timeFrame: Postdose 3 (Month 7)
measure: Geometric Mean Titer for Antibodies to Poliovirus Type 2
timeFrame: Postdose 3 (Month 7)
measure: Geometric Mean Titer for Antibodies to Poliovirus Type 3
timeFrame: Postdose 3 (Month 7)
Secondary 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 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)
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 Pneumococcal Serotypes
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 With Elevated Temperature by Severity
timeFrame: Up to 5 days after any infant vaccination (up to 6 months)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Block SL, Klein NP, Sarpong K, Russell S, Fling J, Petrecz M, Flores S, Xu J, Liu G, Stek JE, Foglia G, Lee AW. Lot-to-lot Consistency, Safety, Tolerability and Immunogenicity of an Investigational Hexavalent Vaccine in US Infants. Pediatr Infect Dis J. 2017 Feb;36(2):202-208. doi: 10.1097/INF.0000000000001405.