Clinical Trials Logo
  1. Home
  2. Vaccines
  3. NCT01461980

A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age

Vaccines Clinical Trial

Official title:
A Phase 2, Randomized, Active-controlled, Observer-blinded Trial, To Assess The Safety, Tolerability, And Immunogenicity Of Mcv4, Tdap Vaccine And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged > = 10 To <13 Years

Clinical Trial Summary

This is a clinical study to assess the safety, tolerance and immunogenic response to MCV4(quadrivalent meningococcal polysaccharide conjugate, meningococcal serogroups A,C,Y, and W135), Tdap (diphtheria, tetanus, and acellular pertussis), and bivalent rLP2086 vaccine. Healthy male and female subjects, between the ages of 10 to 12 years old, will be randomized into 1 of 3 groups. The subjects, investigators, site staff and sponsor will be blinded to all injections given throughout the study. An unblinded administrator will be responsible to administer the vaccinations to all subjects and will be unblinded to the subject randomization in order to determine which subjects were in randomized to group 3 so they may receive their catch-up vaccinations of MCV4 and Tdap. A final telephone contact will be conducted with all subjects 6-months post their last vaccination to obtain safety information.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01461980
Study type Interventional
Source Pfizer
Contact
Status Completed
Phase Phase 2
Start date September 28, 2011
Completion date May 8, 2014
View Details
See also
  Status Clinical Trial Phase
Completed NCT01461993 - A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to Gardasil and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 11 and 17 Phase 2
Not yet recruiting NCT05993325 - Immunogenicity and Safety of AdCLD-CoV19-1 OMI as a Booster: A COVID-19 Preventive Vaccine in Healthy Volunteers Phase 3
Completed NCT02692976 - Natural Dendritic Cells for Immunotherapy of Chemo-naive Metastatic Castration-resistant Prostate Cancer Patients Phase 2
Active, not recruiting NCT05284097 - Ad26.ZEBOV, MVA-BN-Filo Vaccination in Children and Adults Previously Vaccinated With Control in the EBOVAC-Salone Study Phase 2
Recruiting NCT06259487 - Coordinated Vaccination Against RSV and Influenza in Patients With Chronic Heart Failure and Its Impact on Prognosis. N/A
Active, not recruiting NCT05576623 - Safety and Immunogenicity of AdCLD-CoV19-1 OMI as a Booster: A SARS-CoV-2 (COVID-19) Preventive Vaccine Phase 1/Phase 2
Completed NCT03294551 - HPV Centralized R/R RCT #2 - New York State N/A
Not yet recruiting NCT06437834 - Increasing Men's Engagement in Preventive Healthcare Through an Enhanced Cocoon Vaccination Strategy N/A
Completed NCT03666026 - Patient Portal - Flu Reminder Recall N/A
Recruiting NCT05586204 - Boost Intentions and Facilitate Action to Promote COVID-19 Booster Take-up N/A
Recruiting NCT05586165 - Effects of Prompt to Bundle COVID-19 Booster and Flu Shot N/A
Recruiting NCT05586178 - Information Provision and Consistency Framing to Increase COVID-19 Booster Uptake N/A
Completed NCT03294473 - Centralized Reminder Recall - Flu RCT2 N/A
Completed NCT05593042 - Immunogenicity Evaluation of Omicron Variant-based Vaccine and a Trivalent Vaccine in Adults Against COVID-19 in Chile Phase 2
Completed NCT04651790 - Efficacy, Safety, and Immunogenicity of Two Vaccination Schedules of an Inactivated Vaccine Against COVID-19 in Adults Phase 3
Completed NCT01697007 - A Phase II Trial to Assess the Safety and Immunogenicity of DNA Priming Administered by the ID Zetajet® With or Without ID Derma Vax™ Electroporation Followed by IM MVA Boosting in Healthy Volunteers in Tanzania and Mozambique Phase 2
Completed NCT03548337 - Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India Phase 4
Completed NCT02609035 - Immunization Services Model for Adult Rate Improvement N/A
Active, not recruiting NCT05032976 - Korea Comirnaty Post-marketing Surveillance
Completed NCT00340431 - Experimental Vaccine for Plasmodium Falciparum Malaria Phase 1