A phase III, double-blind, randomized, controlled study to evaluate the safety, immunogenicity and efficacy of GlaxoSmithKline Biologicals* HPV 16/18 L1/AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 month) in healthy adult female subjects aged 26 years and above.

A phase III, double-blind, randomized, controlled study to evaluate the safety, immunogenicity and efficacy of GlaxoSmithKline Biologicals* HPV 16/18 L1/AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 month) in healthy adult female subjects aged 26 years and above. - Evaluation of HPV-vaccine efficacy in healthy women of 26 years or above

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38271

Enrollment

360

Registered

2006-01-27

Start date

2006-03-22

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Cervical cancer Human Papillomavirus vaccination

Interventions

One group will receive three HPV (HPV-16/18 L1/AS04) vaccinations (0.5ml, intramuscular) at month 0, 1 en 6 One group will receive three control (Al(OH)3 vaccin) vaccinations (0.5ml, intramuscular)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - A women of at least 26 years of age at the time of the first vaccination - Free of obvious health problems as established by medical history and clinical examination before entering into the study - Subject must have intact cervix (e.g. no history of cauterization or surgical treatment involving damage to the transformation zone of the cervix).

Exclusion criteria

Exclusion criteria: See page 58-60 of the study protocol for a complete list of the in- and exclusion criteria.

Design outcomes

Primary

Measure	Time frame
Co-primary endpoints: * Persistent infection (6-month definition) with HPV-16 or HPV 18 (by PCR) and/or histopathologically-confirmed CIN1+ associated with HPV-16 or HPV-18 cervical infection detected within the lesional component of the cervical tissue specimen (by PCR) (combined endpoint), overall and stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus (by ELISA). * Persistent infection (6-month definition) with HPV-16 or HPV 18 (by PCR) and/or histopathologically-confirmed CIN1+ associated with HPV-16 or HPV-18 cervical infection detected using the HPV TAA, overall and stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus (by ELISA).	—

Measure

Time frame

Co-primary endpoints: * Persistent infection (6-month definition) with HPV-16 or HPV 18 (by PCR) and/or histopathologically-confirmed CIN1+ associated with HPV-16 or HPV-18 cervical infection detected within the lesional component of the cervical tissue specimen (by PCR) (combined endpoint), overall and stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus (by ELISA). * Persistent infection (6-month definition) with HPV-16 or HPV 18 (by PCR) and/or histopathologically-confirmed CIN1+ associated with HPV-16 or HPV-18 cervical infection detected using the HPV TAA, overall and stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus (by ELISA).

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Secondary

Measure	Time frame
Virological endpoints: * Persistent infection (6-month definition) with HPV-16 or HPV-18 (by PCR), overall and stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus (by ELISA). * Persistent infection (12-month definition) with HPV-16 or HPV-18 (by PCR), overall and stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus (by ELISA). * Persistent infection (6-month definition) with oncogenic HPV types (e.g. HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68, by PCR), individually or in combinations, in subjects HPV DNA negative for the type considered, regardless of initial serostatus. * Persistent infection (12-month definition) with oncogenic HPV types (e.g. HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68, by PCR), individually or in combinations, in subjects HPV DNA negative for the type considered, regardless of initial serostatus. Also several histopathological, cytological, immunogenicity and safety secondary endpoints (see protocol page 125-129).	—

Measure

Time frame

Virological endpoints: * Persistent infection (6-month definition) with HPV-16 or HPV-18 (by PCR), overall and stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus (by ELISA). * Persistent infection (12-month definition) with HPV-16 or HPV-18 (by PCR), overall and stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus (by ELISA). * Persistent infection (6-month definition) with oncogenic HPV types (e.g. HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68, by PCR), individually or in combinations, in subjects HPV DNA negative for the type considered, regardless of initial serostatus. * Persistent infection (12-month definition) with oncogenic HPV types (e.g. HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68, by PCR), individually or in combinations, in subjects HPV DNA negative for the type considered, regardless of initial serostatus. Also several histopathological, cytological, immunogenicity and safety secondary endpoints (see protocol page 125-129).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)