Immunogenicity of Gardasil and Twinrix and the Effect of a Dose of Gardasil or Cervarix Given 42 Months Later.

Immunogenicity and Safety of Gardasil and Twinrix Vaccines Co-administered or Administered a Month Apart, According to the 0, 6 Months Schedule and the Effect of a Third Dose of Gardasil or Cervarix Administered 42 Months Later.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01456715

Enrollment

418

Registered

2011-10-21

Start date

2008-09-30

Completion date

2018-12-31

Last updated

2020-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papillomavirus

Keywords

Human Papillomavirus Vaccines, Immunogenicity Gardasil Cervarix, Booster dose

Brief summary

Two human papillomavirus vaccines are now commercially available. No clinical data exist regarding: * The immunogenicity and safety of Gardasil and Twinrix when co-administered. * The immunogenicity and safety of Cervarix when administered to subjects previously vaccinated with Gardasil. The main objective of the first phase of this clinical trial was: • To assess and compare the immunogenicity of Gardasil and Twinrix Junior when co-administered or administered at one month interval according to a 0, 6 month schedule to 9-10 year-old girls. The main objective of the seconde phase of this clinical trial is: • To determine the effect of a booster dose of Gardasil or Cervarix on HPV antibodies when given 42 months post-vaccination of 9-10 year-old girls with two doses of Gardasil. Study Design & Duration: Experimental Design: Blind for the third HPV vaccine dose, randomized, single centre study with two treatment groups. Duration of the study: Participants will be followed for the duration of 10 years post-primary vaccination. Number of Centres: One Center.

Interventions

BIOLOGICALGardasil vaccine, Immunogenicity, Booster dose.

Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Gardasil given 42 months later.

BIOLOGICALCervarix Vaccine, Immunogenicity, Booster Dose.

Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Cervarix given 42 months later.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

12 Years to 14 Years

Healthy volunteers

Yes

Inclusion criteria

* In 2008-2009 received two doses of Gardasil at the age of 9-10 years according to 0, 6 months schedule.

Exclusion criteria

* Received less than two doses of Gardasil or received an HPV vaccine outside the study protocol.

Design outcomes

Primary

Measure	Time frame	Description
Antibody to HPV	1 month post booster dose	The effect of a booster dose of Gardasil or Cervarix administered randomly (1:1) to subjects vaccinated 42 months before with two doses of Gardasil.

Secondary

Measure	Time frame
Safety of a booster dose of Gardasil and Cervarix administered 42 months after the second dose of Gardasil.	Solicited adverse events 5 days post vaccine administration. Serious adverse events during the study period.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026