Human Papillomavirus InfectionNCT01551537
Post-marketing Surveillance of GSK Biologicals' Cervarix™ When Administered to Healthy Females in Sri Lanka
An observational study of Human Papillomavirus Infection, run by GlaxoSmithKline.
Trial summary
This PMS study aims to collect safety and reactogenicity data of Cervarix in the local population as per the licensing requirement of the Sri Lankan regulatory authority. Read more about this study
- Who is it for?
- Ages 10 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Cervarix data collection and Data Collection
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy females aged 10 years and above who will receive Cervarix as a part of routine practice as per the PI in Sri Lanka.
Who may be able to join
- Subjects who the investigator believes that they and/or their parent(s)/ LAR(s) can and will comply with the requirements of the protocol should be enrolled in the PMS study.
- A female aged 10 years and above at the time of the first vaccination.
- Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the parent(s)/LAR(s) of the subject and informed assent must be obtained from the subject. Where subject/subject's parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an impartial witness.
- Subjects of childbearing potential must not be pregnant. Absence of pregnancy should be verified as per the investigator's clinical judgement.
Who cannot join
- Subjects with contraindication according to the locally approved PI.
- Child in care.
- Previous administration of more than two doses of Cervarix.
- Previous vaccination with a HPV vaccine other than Cervarix.
- Planned administration of another HPV vaccine other than Cervarix during the PMS study.
About this study
Official title: Post-marketing Surveillance (PMS) of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) -16/18 Vaccine, Cervarix™ When Administered to Healthy Females According to the Prescribing Information in Sri Lanka
This PMS study aims to collect safety and reactogenicity data of Cervarix in the local population as per the licensing requirement of the Sri Lankan regulatory authority.
Read the detailed description
Subjects who received one or two doses of Cervarix prior to the start of this PMS study can also be enrolled in the study. These subjects would receive either 2 doses or 1 dose respectively after being enrolled in the study.
Since there is lack of clarity regarding the PMS study requirement (both from Regulatory agency and Ethics Committee), it was decided that GSK will submit Local PSURs on a regular basis as desired by Local regulatory agency. The same is communicated to Regulatory agency and if they want something more they are requested to revert back with specific requirements.
- Conditions
- Human Papillomavirus Infection
- Being tested
- Cervarix data collection, Data Collection
- Keywords
- Healthy females, Post-marketing surveillance (PMS), Human papillomavirus vaccine, Sri Lanka, Cervarix
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervarix data collectionOther
Safety monitoring: recording of all AEs during the study period using diary cards, follow-up visit or telephone contact.
Data CollectionOther
All adverse events will be recorded by diary card, follow-up visit or telephone contact.
| Study group | Role | What they receive |
|---|---|---|
| Cohort Group | Healthy females aged 10 years and above will receive 1, 2 or 3 doses of Cervarix as per the Prescribing Information (PI) in Sri Lanka. Receives: Other: Cervarix data collection; Other: Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of solicited local adverse events (AEs).
Measured: During the 7-day period (Days 0-6) following any dose of Cervarix and overall.
Occurrence of solicited general AEs.
Measured: During the 7-day period (Days 0-6) following any dose of Cervarix and overall.
Occurrence of unsolicited AEs.
Measured: During the 30-day period (Days 0-29) following any dose of Cervarix and overall.
Occurrence of any Serious adverse events (SAEs) and SAE(s) causally related to vaccination.
Measured: Throughout the PMS study period (up to six months after the last dose of Cervarix).
Occurrence of potential Immune-Mediated Diseases (pIMDs).
Measured: Throughout the PMS study period (up to six months after the last dose of Cervarix).
Occurrence of Medically Significant Condition (MSCs).
Measured: Throughout the PMS study period (up to six months after the last dose of Cervarix).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startApr 2013
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Why it stopped: Lack of clarity regarding the PMS study requirement from the RA and Ethics committee hence it was concluded GSK will submit local PSURs
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551537
- Sponsor's protocol ID
- 113763
- Status last verified
- Sep 2013
- First submitted
- 8 Mar 2012
- Last updated
- 9 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance (PMS) of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) -16/18 Vaccine, Cervarix™ When Administered to Healthy Females According to the Prescribing Information in Sri Lanka
- ClinicalTrials.gov ID
- NCT01551537
- Acronym / sponsor ID
- 113763
- Conditions
- Human Papillomavirus Infection
- Keywords
- Healthy females, Post-marketing surveillance (PMS), Human papillomavirus vaccine, Sri Lanka, Cervarix
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of clarity regarding the PMS study requirement from the RA and Ethics committee hence it was concluded GSK will submit local PSURs
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This PMS study aims to collect safety and reactogenicity data of Cervarix in the local population as per the licensing requirement of the Sri Lankan regulatory authority.
Detailed description
Subjects who received one or two doses of Cervarix prior to the start of this PMS study can also be enrolled in the study. These subjects would receive either 2 doses or 1 dose respectively after being enrolled in the study.
Since there is lack of clarity regarding the PMS study requirement (both from Regulatory agency and Ethics Committee), it was decided that GSK will submit Local PSURs on a regular basis as desired by Local regulatory agency. The same is communicated to Regulatory agency and if they want something more they are requested to revert back with specific requirements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort Group | – | Other: Cervarix data collection, Other: Data CollectionHealthy females aged 10 years and above will receive 1, 2 or 3 doses of Cervarix as per the Prescribing Information (PI) in Sri Lanka. |
Who may qualify
- Ages
- 10 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy females aged 10 years and above who will receive Cervarix as a part of routine practice as per the PI in Sri Lanka.
Key inclusion criteria (4 listed)
- Subjects who the investigator believes that they and/or their parent(s)/ LAR(s) can and will comply with the requirements of the protocol should be enrolled in the PMS study.
- A female aged 10 years and above at the time of the first vaccination.
- Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the parent(s)/LAR(s) of the subject and informed assent must be obtained from the subject. Where subject/subject's parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an impartial witness.
- Subjects of childbearing potential must not be pregnant. Absence of pregnancy should be verified as per the investigator's clinical judgement.
Key exclusion criteria (5 listed)
- Subjects with contraindication according to the locally approved PI.
- Child in care.
- Previous administration of more than two doses of Cervarix.
- Previous vaccination with a HPV vaccine other than Cervarix.
- Planned administration of another HPV vaccine other than Cervarix during the PMS study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervarix data collectionSafety monitoring: recording of all AEs during the study period using diary cards, follow-up visit or telephone contact. | Other | Cohort Group |
| Data CollectionAll adverse events will be recorded by diary card, follow-up visit or telephone contact. | Other | Cohort Group |
Primary outcome
Occurrence of solicited local adverse events (AEs).
Time frame: During the 7-day period (Days 0-6) following any dose of Cervarix and overall.
Occurrence of solicited general AEs.
Time frame: During the 7-day period (Days 0-6) following any dose of Cervarix and overall.
Occurrence of unsolicited AEs.
Time frame: During the 30-day period (Days 0-29) following any dose of Cervarix and overall.
Occurrence of any Serious adverse events (SAEs) and SAE(s) causally related to vaccination.
Time frame: Throughout the PMS study period (up to six months after the last dose of Cervarix).
Occurrence of potential Immune-Mediated Diseases (pIMDs).
Time frame: Throughout the PMS study period (up to six months after the last dose of Cervarix).
Occurrence of Medically Significant Condition (MSCs).
Time frame: Throughout the PMS study period (up to six months after the last dose of Cervarix).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus Infection, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of solicited local adverse events (AEs). (time frame: During the 7-day period (Days 0-6) following any dose of Cervarix and overall.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2013.