Infections, StreptococcalPhase 2NCT00513409
Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule
A Phase 2 study testing Synflorix, Infanrix Hexa and Havrix in people with Infections, Streptococcal, run by GlaxoSmithKline at 1 site in Chile.
Trial summary
This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose catch-up vaccination. Read more about this study
- Who is it for?
- Ages 18 to 21 monthsHealthy volunteers can take part
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- Synflorix, Infanrix Hexa and Havrix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteChile
- Study dates
- 22 Aug 2007to 28 Aug 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 21 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female between, and including, 18-21 months of age at the time of vaccination.
- Subjects who previously participated in the primary study and received 3 doses of study or control vaccines during the primary study.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Who cannot join
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the booster doses of study vaccines, or planned use during the study period (active phase and extended safety follow-up).
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month (30 days) before the booster doses of vaccine(s) and during the active phase of the study (up to the follow-up visit (Visit 3)).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
- Acute disease at the time of enrolment.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster doses of study vaccines.
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- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- Administration of immunoglobulins and/or any blood products within the last 3 months prior to booster or follow-up vaccination or planned administration during the active phase of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II, Observer-blind Follow-up Study to Assess reacto-and Immunogenicity of GSK Biologicals' Pneumococcal Conjugate Vaccine (GSK1024850A), When Given as Booster in Primed Children or as 2-dose Catch-up in Unprimed Children.
This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose catch-up vaccination.
This protocol posting deals with objectives and outcome measures of the booster phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00338351).
Read the detailed description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
- Conditions
- Infections, Streptococcal
- Being tested
- Synflorix, Infanrix Hexa, Havrix
- Keywords
- Immunogenicity, Pneumococcal disease, Safety, Booster vaccination, Pneumococcal vaccine
- Medical subject headings
- Streptococcal Infections, Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynflorixBiological
Intramuscular injection, 1 or 2 doses
Infanrix HexaBiological
Also called DTPa-HBV-IPV/Hib
1 Intramuscular injection
HavrixBiological
1 Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Synflorix Booster Group | Experimental | Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2). Receives: Biological: Synflorix; Biological: Infanrix Hexa; Biological: Havrix |
| Synflorix Catch-up Group | Experimental | Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2). Receives: Biological: Synflorix; Biological: Infanrix Hexa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)
Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice).
Measured: Within 4 days after the administration of any study vaccine dose
Secondary outcomes (10)
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling.
Measured: Within 4 days after the administration of any study vaccine dose
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite.
Fever was defined as rectal temperature ≥ 38 degrees Celsius.
Measured: Within 4 days after the administration of any study vaccine dose
Number of Subjects Reporting Unsolicited Adverse Events
An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Within 31 days after the administration of any study vaccine dose
Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study
A serious adverse event (SAE) is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Measured: Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose)
Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period
An SAE is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Measured: Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up)
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (μg/mL).
The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.
Measured: Before (pre) and one month after (post) the administration of Dose 2
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8
The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.
Measured: Before (pre) and one month after (post) the administration of Dose 2
Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value
Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
Measured: Before (pre) and one month after (post) the administration of Dose 2
Anti-hepatitis A Virus Antibodies Concentration
Concentration of anti-hepatitis A antibodies given as geometric mean concentration (GMC) in milli-international units per milliliter (mIU/mL).
Measured: Before (pre) and one month after (post) the administration of Dose 2
Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value
Anti-hepatitis A antibodies cut-off value assessed was ≥ 15 mIU/mL.
Measured: Before (pre) and one month after (post) the administration of Dose 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study start22 Aug 2007
- Primary completion20 Feb 2008
- Study completion28 Aug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infections, StreptococcalStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 163 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
- NCT00513409
- Sponsor's protocol ID
- 110031
- Status last verified
- May 2018
- First submitted
- 7 Aug 2007
- Last updated
- 19 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Lagos RE, Munoz AE, Levine MM, Lepetic A, Francois N, Yarzabal JP, Schuerman L. Safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Chilean children. Hum Vaccin. 2011 May;7(5):511-22. doi: 10.4161/hv.7.5.14634. Epub 2011 May 1.
PubMed 21441782Lagos R et al. 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) given as booster dose or 2-dose catch-up in Chilean children. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Observer-blind Follow-up Study to Assess reacto-and Immunogenicity of GSK Biologicals' Pneumococcal Conjugate Vaccine (GSK1024850A), When Given as Booster in Primed Children or as 2-dose Catch-up in Unprimed Children.
- ClinicalTrials.gov ID
- NCT00513409
- Acronym / sponsor ID
- 110031
- Conditions
- Infections, Streptococcal
- Keywords
- Immunogenicity, Pneumococcal disease, Safety, Booster vaccination, Pneumococcal vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2007
- Primary completion
- 20 Feb 2008 (actual)
- Study completion
- 28 Aug 2008 (actual)
- First posted
- 8 Aug 2007 (estimated)
- Results
- Posted 11 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose catch-up vaccination.
This protocol posting deals with objectives and outcome measures of the booster phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00338351).
Detailed description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synflorix Booster Group | Experimental | Biological: Synflorix, Biological: Infanrix Hexa, Biological: HavrixSubjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2). |
| Synflorix Catch-up Group | Experimental | Biological: Synflorix, Biological: Infanrix HexaSubjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2). |
Who may qualify
- Ages
- 18 to 21 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female between, and including, 18-21 months of age at the time of vaccination.
- Subjects who previously participated in the primary study and received 3 doses of study or control vaccines during the primary study.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Key exclusion criteria (10 listed)
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the booster doses of study vaccines, or planned use during the study period (active phase and extended safety follow-up).
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month (30 days) before the booster doses of vaccine(s) and during the active phase of the study (up to the follow-up visit (Visit 3)).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
- Acute disease at the time of enrolment.
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 |
|---|---|---|
| SynflorixIntramuscular injection, 1 or 2 doses | Biological | Synflorix Booster Group, Synflorix Catch-up Group |
| Infanrix HexaAlso: DTPa-HBV-IPV/Hib1 Intramuscular injection | Biological | Synflorix Booster Group, Synflorix Catch-up Group |
| Havrix1 Intramuscular injection | Biological | Synflorix Booster Group |
Primary outcome
Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)
Time frame: Within 4 days after the administration of any study vaccine dose
Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice).
10 secondary outcomes
Number of Subjects Reporting Solicited Local Symptoms
Time frame: Within 4 days after the administration of any study vaccine dose
Number of Subjects Reporting Solicited General Symptoms
Time frame: Within 4 days after the administration of any study vaccine dose
Number of Subjects Reporting Unsolicited Adverse Events
Time frame: Within 31 days after the administration of any study vaccine dose
Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study
Time frame: Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose)
Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period
Time frame: Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up)
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Time frame: Before (pre) and one month after (post) the administration of Dose 2
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Time frame: Before (pre) and one month after (post) the administration of Dose 2
Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value
Time frame: Before (pre) and one month after (post) the administration of Dose 2
Anti-hepatitis A Virus Antibodies Concentration
Time frame: Before (pre) and one month after (post) the administration of Dose 2
Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value
Time frame: Before (pre) and one month after (post) the administration of Dose 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21441782Lagos RE, Munoz AE, Levine MM, Lepetic A, Francois N, Yarzabal JP, Schuerman L. Safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Chilean children. Hum Vaccin. 2011 May;7(5):511-22. doi: 10.4161/hv.7.5.14634. Epub 2011 May 1.
- BackgroundLagos R et al. 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) given as booster dose or 2-dose catch-up in Chilean children. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Synflorix, Infanrix Hexa and Havrix in people with Infections, Streptococcal, run by GlaxoSmithKline at 1 site in Chile.
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 5 inclusion and 10 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 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited) (time frame: Within 4 days after the administration of any study vaccine dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00513409, which also lists 2 linked publications.
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 19 Dec 2018.