Cervical CancerMDINCT01096134
Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention
A study testing HPV Vaccine (Gardasil) in people with Cervical Cancer, run by Jhpiego at 10 sites in 2 countries.
Trial summary
The Mother-Daughter Initiative (MDI) will test the feasibility and acceptability of a strategy to deliver comprehensive cervical cancer prevention services in Thailand and the Philippines by integrating the HPV vaccine for girls ages 9-13 into already successful screening and treatment programs for mothers. Read more about this study
- Who is it for?
- Ages 9 to 13 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- HPV Vaccine (Gardasil)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,000 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jan 2011to Nov 2012
- Phase
- Interventional
- 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 9 to 13 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 9-13 at first HPV vaccine dose
- Mother/legal guardian and daughter are both interested and willing to have the girl receive the HPV vaccine
- Mother/legal guardian and daughter both indicate that they would be able to return to clinic for the three vaccine doses
Who cannot join
- Girls with a known history of any allergies or severe reaction to any vaccines, food or medicine
- Pregnant adolescents will be excluded. If a girl becomes pregnant after the first dose is administered, she will not be provided with the second or third dose
- Girls with moderate or severe illnesses will be asked to postpone vaccination eg. Pneumonia.
- Girls with a weakened immune system, cancer, leukemia, AIDS or other immune system problems
- Girls with a bleeding disorder or currently taking anticoagulants
- Girls that have received any other vaccinations in the past 4 weeks
- Girls currently on steroids, such as cortisone, prednisone, or anti-cancer drug.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Thailand7 sites
Ban Yuanlae District Health Center
Ban Phon Ko
Health promotion Clinic Number 11
Nakhon Si Thammarat, Nakisron
Ban Pak Poon Health Center
Nakhon Si Thammarat, Nakornsri
Maharat Nakhonsithammarat Primary Care Unit
Nakhon Si Thammarat, Nakornsri
Pak-Panung District Health Center
Nakhon Si Thammarat, Nakornsri
Ban Mai Daeng
Nakhon Si Thammarat, Nakornsri
Ban Pai Ta Health Center
Nakhon Si Thammarat, Nakornsri
Philippines3 sites
Minglanilla
Cebu
Los Banos
Quezon
Pagbilao Health Center
Quezon
About this study
The Mother-Daughter Initiative (MDI) will test the feasibility and acceptability of a strategy to deliver comprehensive cervical cancer prevention services in Thailand and the Philippines by integrating the HPV vaccine for girls ages 9-13 into already successful screening and treatment programs for mothers.
- Conditions
- Cervical Cancer
- Being tested
- HPV Vaccine (Gardasil)
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV Vaccine (Gardasil)Biological
HPV Vaccine Administration: According to the CDC, Gardasil should be delivered through a series of three intra-muscular injections over a six-month period. The second and third doses should be given two and six months after the first dose. The vaccine can be administered at the same visit as other age-appropriate vaccines, such as Tdap, Td, MCV4, influenza, and hepatitis B vaccines. Providers should consider a 15-minute waiting period for vaccine recipients following vaccination.
FDA's Approval of Gardasil (June 8, 2006) lists the following information on product Formulation: Each 0.5 mL dose of the vaccine contains:
20 mcg of HPV 6 L1 protein 40 mcg of HPV 11 L1 protein 40 mcg of HPV 16 L1 protein 20 mcg of HPV 18 L1 protein 225 mcg aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant) 9.56 mg of sodium chloride 0.78 mg of L-histidine 50 mcg of polysorbate 80 35 mcg of sodium borate water for injection
| Study group | Role | What they receive |
|---|---|---|
| HPV Vaccine | Experimental | Eligible girls were offered 3 doses of the HPV vaccine Receives: Biological: HPV Vaccine (Gardasil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the population coverage of HPV vaccination of girls aged 9-13 offered within the context of cervical cancer screening and treatment of mothers
The aim of the study to assess whether we can fully vaccinate (all 3 doses),50% of girls aged 9 -13 in the participating districts, in an 18-month period. This corresponds to 4000 girls in Thailand and 4000 in Phillipines. The study will seek to undertand if this level of population coverage (50%), can be achieved through encouraging women that recive cervical cancer screening to bring in their daughters or relatives for vaccination.
Measured: 18 months
Secondary outcomes (2)
Assess mothers' acceptability of having their daughters receive the full course of HPV vaccine after mothers receive screening and treatment services for cervical pre-cancer
Data on mothers knowledge of the vaccine, and intention to have their daughters vaccinated will be collected for a period of 1 year (or when the target number of 700 women/guardians is reached, whatever comes first).
Data will be collected on:
- Proportion of women with daughters who intend to vaccinate their daughters.
- Proportion of daughters of screened mothers who return to receive the vaccine.
- Proportion of girls who receive the first vaccine dose and are brought to the facility by a guardian/mother who did NOT recieve cervical cancer screening
Measured: 1 year
Inform future programs that aim to introduce the HPV vaccine in the context of secondary screening for cervical cancer by determining the factors related to screened women bringing daughters for HPV vaccination and the costs of vaccine introduction
Programmatic data will be collected for the duration of the project, including but not limited to:
- Cost required to implement the program
- Logistics required to ensure supply and appropriate maintenance of vaccine
- Human resources required to effectively adminster the vaccine as part of routine services.
- Key communication and outreach messages that effectively educate the community
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startJan 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Sharon Kibwana, Jhpiego
- Investigators
- Cecilia Llave, MD, Principal investigator, Cancer Institute Foundation, PhillipinesKobchitt Limpaphayom, MD, Principal investigator, Chulalongkorn University, ThailandEnriquito Lu, MD, MPH, Principal investigator, Jhpiego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096134
- Sponsor's protocol ID
- 36448
- Acronym
- MDI
- Status last verified
- Oct 2015
- First submitted
- 23 Mar 2010
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention
- ClinicalTrials.gov ID
- NCT01096134
- Acronym / sponsor ID
- MDI / 36448
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,000 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 30 Mar 2010 (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.
The Mother-Daughter Initiative (MDI) will test the feasibility and acceptability of a strategy to deliver comprehensive cervical cancer prevention services in Thailand and the Philippines by integrating the HPV vaccine for girls ages 9-13 into already successful screening and treatment programs for mothers.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV Vaccine | Experimental | Biological: HPV Vaccine (Gardasil)Eligible girls were offered 3 doses of the HPV vaccine |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 9-13 at first HPV vaccine dose
- Mother/legal guardian and daughter are both interested and willing to have the girl receive the HPV vaccine
- Mother/legal guardian and daughter both indicate that they would be able to return to clinic for the three vaccine doses
Key exclusion criteria (7 listed)
- Girls with a known history of any allergies or severe reaction to any vaccines, food or medicine
- Pregnant adolescents will be excluded. If a girl becomes pregnant after the first dose is administered, she will not be provided with the second or third dose
- Girls with moderate or severe illnesses will be asked to postpone vaccination eg. Pneumonia.
- Girls with a weakened immune system, cancer, leukemia, AIDS or other immune system problems
- Girls with a bleeding disorder or currently taking anticoagulants
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 |
|---|---|---|
| HPV Vaccine (Gardasil)HPV Vaccine Administration: According to the CDC, Gardasil should be delivered through a series of three intra-muscular injections over a six-month period. The second and third doses should be given two and six months after the first dose. The vaccine can be administered at the same visit as other age-appropriate vaccines, such as Tdap, Td, MCV4, influenza, and hepatitis B vaccines. Providers should consider a 15-minute waiting period for vaccine recipients following vaccination. FDA's Approval of Gardasil (June 8, 2006) lists the following information on product Formulation: Each 0.5 mL dose of the vaccine contains: 20 mcg of HPV 6 L1 protein 40 mcg of HPV 11 L1 protein 40 mcg of HPV 16 L1 protein 20 mcg of HPV 18 L1 protein 225 mcg aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant) 9.56 mg of sodium chloride 0.78 mg of L-histidine 50 mcg of polysorbate 80 35 mcg of sodium borate water for injection | Biological | HPV Vaccine |
Primary outcome
Determine the population coverage of HPV vaccination of girls aged 9-13 offered within the context of cervical cancer screening and treatment of mothers
Time frame: 18 months
The aim of the study to assess whether we can fully vaccinate (all 3 doses),50% of girls aged 9 -13 in the participating districts, in an 18-month period. This corresponds to 4000 girls in Thailand and 4000 in Phillipines. The study will seek to undertand if this level of population coverage (50%), can be achieved through encouraging women that recive cervical cancer screening to bring in their daughters or relatives for vaccination.
2 secondary outcomes
Assess mothers' acceptability of having their daughters receive the full course of HPV vaccine after mothers receive screening and treatment services for cervical pre-cancer
Time frame: 1 year
Inform future programs that aim to introduce the HPV vaccine in the context of secondary screening for cervical cancer by determining the factors related to screened women bringing daughters for HPV vaccination and the costs of vaccine introduction
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
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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.
Cecilia Llave, MD principal investigator
Cancer Institute Foundation, Phillipines
Kobchitt Limpaphayom, MD principal investigator
Chulalongkorn University, Thailand
Enriquito Lu, MD, MPH principal investigator
Jhpiego
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV Vaccine (Gardasil) in people with Cervical Cancer, run by Jhpiego at 10 sites in 2 countries.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Thailand, Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the population coverage of HPV vaccination of girls aged 9-13 offered within the context of cervical cancer screening and treatment of mothers (time frame: 18 months). 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 12 Oct 2015.