NCT01249183|CompletedPhase 3

Safety and Immunogenicity Study of Concomitant Versus Non Concomitant Administration of a Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccine (REPEVAX) and Influenza Vaccine (VAXIGRIP) in Subjects Aged From 60 Years Old

An Open-label, Randomised, Multicentre Study to Evaluate the Immunogenicity and Safety of a Booster Dose of Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Adsorbed Vaccine (REPEVAX) Administered Concomitantly Versus Non-concomitantly With an Influenza Vaccine (VAXIGRIP) to Subjects of 60 Years of Age and Older

Sanofi Pasteur, a Sanofi Company ClinicalTrials.gov

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1 other identifier

RPV03C

Study Type

interventional

Target

954

Locations

2 countries

Sites

Timeline

RegisteredNov 2010

StartedOct 2010

CompletionSep 2011

Brief Summary

Primary objectives: To demonstrate that REPEVAX and VAXIGRIP administered concomitantly in subjects 60 years of age and older are at least as immunogenic as REPEVAX or VAXIGRIP administered separately. Secondary objectives:

Secondary immunogenicity objectives: To describe the immune responses 28 days after concomitant or separate administration of REPEVAX and VAXIGRIP in subjects 60 years of age and older To describe the immune response of VAXIGRIP according to European Medicines Agency criteria in subjects 60 years of age and older (Note for Guidance, 1997: 28)
Secondary safety objective: To describe the safety profile after vaccination in each group

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

954

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Oct 2010

Shorter than P25 for phase_3

Geographic Reach

2 countries

20 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 months study duration

Study Start

First participant enrolled

October 1, 2010

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2010

Completed

12 days until next milestone

First Posted

Study publicly available on registry

November 29, 2010

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed

Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

November 17, 2010

Last Update Submit

September 8, 2017

Conditions

Diphtheria Tetanus Pertussis Poliomyelitis

Keywords

DiphtheriaTetanusPertussis (acellular, component)DiphteriaBiological / vaccine

Outcome Measures

Primary Outcomes (5)

Diphtheria seroprotection rate
28 to 35 days after vaccine administration
Tetanus seroprotection rate
28 to 35 days after vaccine administration
Polio seroprotection rate
28 to 35 days after vaccine administration
Pertussis antibody titre
28 to 35 days after vaccine administration
Flu geometric mean of titres ratio
28 to 35 days after vaccine administration

Secondary Outcomes (3)

Solicited injection-site reactions, solicited systemic adverse reactions
From Day 0 to Day 7 following REPEVAX vaccination
Unsolicited injection-site adverse reactions and systemic adverse events
From Day 0 to Day 28 following REPEVAX and/or VAXIGRIP vaccination
Number and proportion of Serious adverse events
From the first visit to the last visit of the subject

Study Arms (2)

1- VAXIGRIP and REPEVAX concomitantly

EXPERIMENTAL

Biological: Concomitant administration

2-REPEVAX 28 days after VAXIGRIP

ACTIVE COMPARATOR

Biological: Separate administration

Interventions

Concomitant administrationBIOLOGICAL

1 dose (0.5 mL) of VAXIGRIP and 1 dose (0.5 mL) of REPEVAX in 2 separate injections sites (1 on each arm)

1- VAXIGRIP and REPEVAX concomitantly

Separate administrationBIOLOGICAL

1 dose (0.5 mL) of VAXIGRIP at Day 0 and 1 dose (0.5 mL) of REPEVAX 28 days later

2-REPEVAX 28 days after VAXIGRIP

Eligibility Criteria

Age60 Years - 99 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adults aged ≥60 years
At least one documented booster dose with a tetanus- and diphtheria-containing vaccine between 5 and 15 years
No influenza vaccine administered during the last 6 months

You may not qualify if:

Receipt of a booster dose with a tetanus or diphtheria- or poliomyelitis- containing vaccine within the last 5 years
Receipt of pertussis-containing vaccine or pertussis disease within the last 10 years
Receipt of medication / vaccine that may interfere with study assessments
Febrile illness or moderate or severe acute illness/infection
History of hypersensitivity or anaphylactic or other allergic reactions to any of the vaccine components, or history of a life-threatening reaction to the study vaccines or a vaccine containing any of the same substances
History of Guillain Barré syndrome or brachial neuritis following a previous vaccination
History of encephalopathy of unknown origin within 7 days after immunization with a pertussis-containing vaccine or unstable neurological disorders
Known or suspected immune dysfunction
Thrombocytopenia, bleeding disorder or anticoagulants contraindicating intramuscular vaccination
Chronic disease that is unstable or any intercurrent illness that might interfere with the ability to participate fully in the study; or interfere with evaluation of the vaccine

Contact the study team to confirm eligibility.