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NCT00443846

RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)

Completed Phase 3 Results posted Last updated 20 June 2018
What this trial tests

Phase 3 trial testing RotaTeq® in Meningitis, Meningococcal in 247 participants. Completed in 23 October 2007.

Timeline
13 February 2007
Primary endpoint
4 September 2007
23 October 2007

Quick facts

Lead sponsorMerck Sharp & Dohme LLC
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment247
Start date13 February 2007
Primary completion4 September 2007
Estimated completion23 October 2007

Drugs / interventions tested

Conditions studied

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 42 Days to 55 Days, any sex, with Meningitis, Meningococcal or Rotavirus Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype Primary · 28 days after the second dose of MCC vaccine (approximately 20 weeks)

Antibody seroprotection to meningiococcal Group C serotype was measured by serum bactericidal antibody with rabbit complement (sRBA). The criterion for seroresponse was an sRBA titer \>=1:8.

GroupValue95% CI
Group 1: Concomitant Administration10096.5 – 100
Group 2: Sequential Administration10096.6 – 100

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group 1: Concomitant Administration
Serious: 1/116 (1%)
Deaths:
Group 2: Sequential Administration
Serious: 1/122 (1%)
Deaths:

Serious adverse events (2 terms)

ReactionSystemGroup 1: Concomitant Admin…Group 2: Sequential Admini…
Viral infectionInfections and infestations
EpilepsyNervous system disorders
Other adverse events (19 terms — click to expand)

ReactionSystemGroup 1: Concomitant Admin…Group 2: Sequential Admini…
IrritabilityGeneral disorders
DiarrhoeaGastrointestinal disorders
PyrexiaGeneral disorders
VomitingGastrointestinal disorders
Injection-site erythemaGeneral disorders
CryingPsychiatric disorders
FlatulenceGastrointestinal disorders
RhinitisInfections and infestations
Abdominal pain upperGastrointestinal disorders
Regurgitation of foodGastrointestinal disorders
Injection-site painGeneral disorders
Injection-site swellingGeneral disorders
Upper respiratory tract infectionInfections and infestations
SomnolenceNervous system disorders
RashSkin and subcutaneous tissue disorders
ConjunctivitisEye disorders
TeethingGastrointestinal disorders
Injection-site indurationGeneral disorders
CoughRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Viral infection, Epilepsy.

Data from ClinicalTrials.gov NCT00443846 adverse events section.

Sponsor's own description

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®.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Results from a randomized clinical trial of coadministration of RotaTeq, a pentavalent rotavirus vaccine, and NeisVac-C, a meningococcal serogroup C conjugate vaccine.
    Vesikari T, Karvonen A, Borrow R, Kitchin N, et al · · 2011 · cited 9× · PMID 21389149 · DOI 10.1128/cvi.00437-10
  2. Systematic literature review on the safety and immunogenicity of rotavirus vaccines when co-administered with meningococcal vaccines.
    Pereira P, Benninghoff B, Moerman L. · · 2020 · cited 5× · PMID 32298219 · DOI 10.1080/21645515.2020.1739485

Verify or expand the search:

Other trials of RotaTeq®

Trials testing the same drug.

Other recruiting trials for Meningitis, Meningococcal

Currently open trials in the same condition.

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00443846.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing