Phase 3
Completed N=247
RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)
Meningitis, Meningococcal · Rotavirus Infections
Source: ClinicalTrials.gov NCT00443846 ↗
Enrolled (actual)
247
Serious AEs
0.8%
Results posted
Jun 2018
Primary outcomePrimary: Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype — 100; 100 Percentage of participants
◆ Published Evidence
Emerging
13citations · ~1 / year
Results from a randomized clinical trial of coadministration of RotaTeq, a pentavalent rotavirus vaccine, and NeisVac-C, a meningococcal serogroup C conjugate vaccine.
Summary
Primary objective:
To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine. The hypothesis tested is that the seroprotection rate for MMC at 28 days after the second MCC vaccination with concomitant administration of RotaTeq® is non-inferior to that without non-concomitant (sequential) administration of RotaTeq®.
Linked Publications
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Results from a randomized clinical trial of coadministration of RotaTeq, a pentavalent rotavirus vaccine, and NeisVac-C, a meningococcal serogroup C conjugate vaccine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype |
100; 100 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy infants, aged from 6 weeks through full 7 weeks,
- Consent form signed by at least one parent 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
- History of congenital abdominal disorders, congenital malformation of the gastrointestinal tract that could predispose to intussusception, or abdominal surgery,
- Congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency,
- Known or suspected impairment of immunological function,
- Known hypersensitivity to any component of RotaTeq® (e.g. sucrose) or of NeisVac-C® (including tetanus toxoid),
- Prior administration of any rotavirus vaccine,
- Prior administration of any vaccine within the 28 days prior to randomisation,
- Fever (rectal temperature ≥38.1°C) and/or acute diarrhoea and/or vomiting at randomisation,
- History of known prior rotavirus gastroenteritis, chronic diarrhoea, or failure to thrive,
- Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
- Clinical evidence of active gastrointestinal illness,
- Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 14 days prior to randomisation. Note: Infants on inhaled and/or topical steroids may participate in the study,
- Infants residing in a household with an immunocompromised person,
- Prior receipt of a blood transfusion or blood products, including immunoglobulins.
Data sourced from ClinicalTrials.gov (NCT00443846) 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.