Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035)

Phase 3

Completed

• Conditions: Mumps; Haemophilus Infections; Varicella; Diphtheria; Pertussis; Measles; Rubella; Poliomyelitis; Tetanus; Hepatitis B
• Interventions: Biological: ProQuad®; Biological: Infanrix® hexa

• Registration Number: NCT00432042
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Primary Objective:

* To demonstrate that ProQuad® can be administered concomitantly with a booster dose of Infanrix® hexa to healthy children 12 to 23 months of age without impairing either the antibody response rates to measles, mumps, rubella, varicella, hepatitis B and Haemophilus influenzae type b; or to the 3 pertussis antibody titres measured at 42 days following vaccination.

Secondary Objectives:

* To describe the antibody titres and the antibody response rates to measles, mumps, rubella, varicella, diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b as measured at 42 days following vaccination by an Infanrix® hexa primary series schedule and all data are pooled.

* To evaluate the safety profile of ProQuad® when administered concomitantly with a booster dose of Infanrix® hexa by an Infanrix® hexa primary series schedule and all data are pooled.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-01-12
• Study First Submitted: 2007-02-05
• Study First Submitted QC: 2007-02-05
• Study First Posted: 2007-02-06
• Primary Completion: 2008-03-27
• Study Completion: 2008-03-27
• Results First Submitted: 2017-09-01
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-19
• Last Update Submitted: 2018-02-19
• Results First Posted: 2018-03-19
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 955

Inclusion Criteria

• Healthy participants of either gender
• Aged 12 to 23 months
• No clinical history of measles, mumps, rubella, varicella and zoster
• For Italy: Primary vaccination with the combined diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine Infanrix® hexa as a 2-dose schedule, with receipt of the second dose ≥ 6 months prior to inclusion
• For Germany: Primary vaccination with the combined diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine Infanrix® hexa as a 3-dose schedule, with receipt of the third dose ≥ 6 months prior to inclusion
• Consent form signed by parent(s) according to local regulations or by the legal representative properly informed about the study
• Parent(s)/legal representative able to understand the protocol requirements and to fill in the Diary Card.

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Exclusion Criteria

• Prior receipt of measles, mumps, rubella and/or varicella vaccine either alone or in any combination
• Any recent (<= 30 days) exposure to measles, mumps, rubella, varicella and/or zoster
• Receipt of any other diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenzae type b containing vaccine (either alone or in any combination) than Infanrix® hexa
• Any recent (<= 3 days) history of febrile illness
• Any severe chronic disease
• Active untreated tuberculosis
• Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition
• Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic or lymphatic systems
• Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
• Prior known sensitivity/allergy to any component of the vaccines including neomycin, sorbitol or gelatin
• Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity
• Any recent (<= 2 days) tuberculin test or scheduled tuberculin test through Visit 2
• Any previous (<= 150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through Visit 2
• Any recent (<= 30 days) receipt of an inactivated or a live non-study vaccine or scheduled non-study vaccination through Visit 2
• Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
• Any recent (≤30 days) participation or scheduled participation in any other clinical trial through Visit 2

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ProQuad® + Infanrix® hexa	ProQuad®	Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
ProQuad® + Infanrix® hexa	Infanrix® hexa	Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
ProQuad®	ProQuad®	Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
Infanrix® hexa	Infanrix® hexa	Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Meeting Antibody Response Rate Criteria to Measles, Mumps, Rubella, and Varicella	Day 42	The percentage of participants with seronegative baseline values who met antibody response criteria in Arm 1: ProQuad® + Infanrix® hexa and Arm 2: ProQuad® was determined. Post-vaccination antibody response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre \<255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre \<10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre \<10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre \<1.25 gpELISA units/mL. Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA).
Percentage of Participants Meeting Post-vaccination Antibody Response Rates to Hepatitis B and Haemophilus Influenzae Type B	Day 42	The percentage of participants with seronegative baseline values who met antibody response criteria in Arm 1: ProQuad® + Infanrix® hexa and Arm 3: Infanrix® hexa was determined. Post-vaccination antibody response and baseline seronegativity criteria were as follows: Hepatitis B antibody titre ≥10 IU/mL and Haemophilus Influenzae Type b antibody titre ≥1 ug/mL. Hepatitis B antibody levels were determined using anti-HBs ORTHO ECi Immunodiagnostic Assay. Haemophilus Influenzae Type b antibody (anti-polyribosylribitol phosphate \[PRP\]) levels were determined with radioimmunoassay (RIA) or with enzyme immunoassay (EIA).
Post-vaccination Geometric Mean Titres (GMT) to Pertussis	Day 42	The GMT to pertussis were compared in Arm1: ProQuad® + Infanrix® hexa and Arm 3: Infanrix® hexa. Anti-pertussis toxin (anti-PT), anti-filamentous hemagglutinin (anti-FHA), and anti-pertactin (anti-PRN) were determined using ELISA on solid phase based on sandwich principle.