Phase 3
Completed N=955
Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035)
Source: ClinicalTrials.gov NCT00432042 ↗Enrolled (actual)
955
Serious AEs
1.8%
Results posted
Mar 2018
Primary outcomePrimary: Percentage of Participants Meeting Antibody Response Rate Criteria to Measles, Mumps, Rubella, and Varicella — 97.4; 96.3; 96.7; 98.6 Percentage of Participants
◆ Published Evidence
Emerging
13citations · ~1 / year
Immunogenicity and safety of a combined measles, mumps, rubella and varicella live vaccine (ProQuad ®) administered concomitantly with a booster dose of a hexavalent vaccine in 12-23-month-old infants.
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.
Linked Publications
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Immunogenicity and safety of a combined measles, mumps, rubella and varicella live vaccine (ProQuad ®) administered concomitantly with a booster dose of a hexavalent vaccine in 12-23-month-old infants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Meeting Antibody Response Rate Criteria to Measles, Mumps, Rubella, and Varicella |
97.4; 96.3; 96.7; 98.6; 97.9; 99.1 | — |
| PRIMARY Percentage of Participants Meeting Post-vaccination Antibody Response Rates to Hepatitis B and Haemophilus Influenzae Type B |
99.5; 98.1; 98.2; 95.3 | — |
| PRIMARY Post-vaccination Geometric Mean Titres (GMT) to Pertussis |
132.6; 139.1; 210.9; 189.9; 310.0; 259.7 | — |
Eligibility Criteria
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.
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
Data sourced from ClinicalTrials.gov (NCT00432042) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.