Infections, StreptococcalPhase 3NCT00814710

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age

A Phase 3 study testing Pneumococcal conjugate vaccine GSK1024850A, Tritanrix-HepB/Hib and Hiberix in people with Infections, Streptococcal and Streptococcus Pneumoniae, run by GlaxoSmithKline at 4 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Indian infants with pneumococcal conjugate vaccine GSK1024850A co-administered with a… Read more about this study

Who is it for?: Ages 6 to 10 weeksHealthy volunteers can take part
Conditions the study is for: Infections, Streptococcal, Streptococcus Pneumoniae
What is being tested?: Pneumococcal conjugate vaccine GSK1024850A, Tritanrix-HepB/Hib and Hiberix
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 360 participants
Where: 4 sitesIndia
Study dates: 7 Mar 2009to 13 Nov 2009
Phase: Phase 3
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 6 to 10 weeks
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
Free of any known or suspected 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 product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
A family history of congenital or hereditary immunodeficiency.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immunoglobulins at birth).

Show all 13Show fewer

Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of hepatitis B vaccination at birth or at least 30 days before the subject's first study visit).
History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
History of any neurological disorders or seizures.
Major congenital defects or serious chronic illness.
Acute disease at the time of enrolment.
Babies for which birth weight is < 2 kilogram.

Trial locations and contacts

4 sites in 1 country.

India4 sites

GSK Investigational Site
Kolkata, 700073
GSK Investigational Site
Ludhiana, 141 008
GSK Investigational Site
Pune
GSK Investigational Site
Vellore, 632004

Other trials in India

About this study

Official title: Primary Vaccination Course in Healthy Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Tritanrix™-HepB/Hib at 6, 10 and 14 Weeks of Age

Conditions: Infections, Streptococcal, Streptococcus Pneumoniae
Being tested: Pneumococcal conjugate vaccine GSK1024850A, Tritanrix-HepB/Hib, Hiberix, Tritanrix-HepB
Keywords: Pneumococcal disease, Pneumococcal vaccine, Safety, Primary vaccination, Immunogenicity
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.

Pneumococcal conjugate vaccine GSK1024850ABiological
Intramuscular injection, 3 doses
Tritanrix-HepB/HibBiological
Also called DTPw-HBV/Hib
Intramuscular injection, 3 doses
HiberixBiological
Also called Hib
Intramuscular injection, 3 doses
Tritanrix-HepBBiological
Also called DTPw-HBV
Intramuscular injection, 3 doses

Study groups in NCT00814710
Study group	Role	What they receive
Synflorix & Tritanrix-HebB/Hib Group	Experimental	Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2) Receives: Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: Tritanrix-HepB/Hib
Hiberix group & Tritanrix-HebB Group	Active comparator	Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2) Receives: Biological: Hiberix; Biological: Tritanrix-HepB

What is being measured

The primary outcome is the main question the study is designed to answer.

Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes
Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL).
Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Measured: One month after primary immunization (month 3)
Concentration of Antibody Against Protein D (PD)
Concentrations were expressed as GMCs GSK's 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Measured: One month after primary immunization (month 3)

Secondary outcomes (15)

Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes
Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Cross-reactive pneumococcal serotypes included 6A and 19A.
Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8.
Measured: One month after primary immunization (month 3)
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value
Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.
The cut-off was defined as 0.20 microgram per milliliter (µg/mL).
Measured: One month after primary immunization
Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes
Concentrations were expressed as GMCs in µg/mL. Pneumococcal cross-reactive serotypes included 6A and 19A.
Measured: One month after primary immunization (month 3)
Number of Subjects Seropositive for Pneumococcal Serotypes
Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.
Seropositivity was defined as a titer equal to or greater than 0.05 µg/mL
Measured: One month after primary immunization (month 3)
Number of Subjects Seropositive for Protein D (PD)
Seropositivity for PD was defined greater than or equal to 100 EL.U/mL.
Measured: One month after primary immunization (month 3)
Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)
Concentration is expressed as GMC in µg/mL.
Measured: One month after primary immunization (month 3)
Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT)
Concentrations were expressed as GMCs in international units per milliliter (IU/mL).
Measured: One month after primary immunization (month 3)
Concentration of Antibody Against Bordetella Pertussis (B. Pertussis)
Concentration was expressed as GMC in EL.U/mL.
Measured: One month after primary immunization (month 3)
Concentration of Antibody Against Hepatitis B (Anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA).
Concentration was expressed as GMC in milli international units per milliliter (mIU/mL). As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table shows results following partial or complete retesting/reanalysis.
Measured: One month after primary immunization (month 3)
Number of Subjects Seropostive for B. Pertussis
Seropositivity was defined as and antibody concentration equal to or greater than 15 EL.U/mL.
Measured: One month after primary immunization (month 3)
Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs)
Seroprotection was defined as:
Anti-DT antibody concentration equal to or greater than 0.1 IU/mL. Anti-TT antibody concentration equal to or greater than 0.1 IU/mL. Anti-PRP antibody concentration equal to or greater than 0.15 µg/mL Anti-HBs antibody concentration greater than or equal to 10 mIU/mL.
Measured: One month after primary immunization (month 3)
Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL)
Anti-PRP antibody concentration equal to or greater than 1.0 µg/mL.
Measured: One month after primary immunization (month 3)
Number of Subjects With Solicited Local and General Symptoms
Solicited local symptoms included pain, redness and swelling. Solicited general symptoms included drowsiness, fever (equal to or above 38 degrees Celsius and above 39 degrees Celsius), irritability and loss of appetite.
Measured: Within 4 days (day 0-3) after vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
An AE 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.
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms
Measured: Within 31 days (day 0-30) after vaccination
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: Following first vaccination (Month 0) throughout the entire study period (month 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Mar 200913 Nov 2009

First posted25 Dec 2008 (estimated)
Study start7 Mar 2009
Primary completion13 Nov 2009
Study completion13 Nov 2009

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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 360 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00814710
Sponsor's protocol ID: 111188
Other IDs: 2011-004644-22
Status last verified: Dec 2019
First submitted: 23 Dec 2008
Last updated: 3 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

Publications

Lalwani S, Chatterjee S, Chhatwal J, Verghese VP, Mehta S, Shafi F, Borys D, Moreira M, Schuerman L. Immunogenicity, safety, and reactogenicity of the 10-valent pneumococcal non-typeable Hemophilus influenzae protein D conjugate vaccine (PHiD-CV) when co-administered with the DTPw-HBV/Hib vaccine in Indian infants: a single-blind, randomized, controlled study. Hum Vaccin Immunother. 2012 May;8(5):612-22. doi: 10.4161/hv.19287. Epub 2012 May 1.
PubMed 22634448
Lalwani S, Chatterjee S, Chhatwal J, Simon A, Ravula S, Francois N, Mehta S, Strezova A, Borys D. Randomized, open-label study of the impact of age on booster responses to the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in children in India. Clin Vaccine Immunol. 2014 Sep;21(9):1292-300. doi: 10.1128/CVI.00068-14. Epub 2014 Jul 9.
PubMed 25008901

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Infections, Streptococcal trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Primary Vaccination Course in Healthy Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Tritanrix™-HepB/Hib at 6, 10 and 14 Weeks of Age
ClinicalTrials.gov ID: NCT00814710
Acronym / sponsor ID: 111188
Conditions: Infections, Streptococcal, Streptococcus Pneumoniae
Keywords: Pneumococcal disease, Pneumococcal vaccine, Safety, Primary vaccination, Immunogenicity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 360 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 7 Mar 2009 (actual)
Primary completion: 13 Nov 2009 (actual)
Study completion: 13 Nov 2009 (actual)
First posted: 25 Dec 2008 (estimated)
Results: Posted 29 Oct 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Synflorix & Tritanrix-HebB/Hib Group	Experimental	Biological: Pneumococcal conjugate vaccine GSK1024850A, Biological: Tritanrix-HepB/HibSubjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Hiberix group & Tritanrix-HebB Group	Active comparator	Biological: Hiberix, Biological: Tritanrix-HepBSubjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

Who may qualify

Ages: 6 to 10 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study).

Key exclusion criteria (13 listed)

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
A family history of congenital or hereditary immunodeficiency.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.

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
Pneumococcal conjugate vaccine GSK1024850AIntramuscular injection, 3 doses	Biological	Synflorix & Tritanrix-HebB/Hib Group
Tritanrix-HepB/HibAlso: DTPw-HBV/HibIntramuscular injection, 3 doses	Biological	Synflorix & Tritanrix-HebB/Hib Group
HiberixAlso: HibIntramuscular injection, 3 doses	Biological	Hiberix group & Tritanrix-HebB Group
Tritanrix-HepBAlso: DTPw-HBVIntramuscular injection, 3 doses	Biological	Hiberix group & Tritanrix-HebB Group

Primary outcome

Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes
Time frame: One month after primary immunization (month 3)
Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL). Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Concentration of Antibody Against Protein D (PD)
Time frame: One month after primary immunization (month 3)
Concentrations were expressed as GMCs GSK's 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

15 secondary outcomes

Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes
Time frame: One month after primary immunization (month 3)
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value
Time frame: One month after primary immunization
Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes
Time frame: One month after primary immunization (month 3)
Number of Subjects Seropositive for Pneumococcal Serotypes
Time frame: One month after primary immunization (month 3)
Number of Subjects Seropositive for Protein D (PD)
Time frame: One month after primary immunization (month 3)
Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)
Time frame: One month after primary immunization (month 3)
Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT)
Time frame: One month after primary immunization (month 3)
Concentration of Antibody Against Bordetella Pertussis (B. Pertussis)
Time frame: One month after primary immunization (month 3)
Concentration of Antibody Against Hepatitis B (Anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA).
Time frame: One month after primary immunization (month 3)
Number of Subjects Seropostive for B. Pertussis
Time frame: One month after primary immunization (month 3)
Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs)
Time frame: One month after primary immunization (month 3)
Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL)
Time frame: One month after primary immunization (month 3)
Number of Subjects With Solicited Local and General Symptoms
Time frame: Within 4 days (day 0-3) after vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: Within 31 days (day 0-30) after vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: Following first vaccination (Month 0) throughout the entire study period (month 3)

Results and safety

Results posted to the registry on 29 Oct 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Synflorix and Tritanrix-HepB/Hib Group	240	232
Hiberix Group and Tritanrix-HepB Group	120	117

Primary outcome: Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes

Time frame: One month after primary immunization (month 3). Geometric mean (95% Confidence Interval). Unit: µg/mL

Measure	Synflorix and Tritanrix-HepB/Hib Group n = 229	Hiberix Group and Tritanrix-HepB Group n = 116
Anti-1	3.27 (2.91 to 3.67)	0.03 (0.03 to 0.04)
Anti-4	3.80 (3.33 to 4.33)	0.04 (0.03 to 0.05)
Anti-5	4.17 (3.72 to 4.67)	0.05 (0.04 to 0.05)
Anti-6B	0.71 (0.59 to 0.86)	0.05 (0.04 to 0.06)
Anti-7F	3.87 (3.47 to 4.31)	0.06 (0.05 to 0.07)
Anti-9V	4.21 (3.71 to 4.78)	0.06 (0.05 to 0.08)
Anti-14	5.21 (4.51 to 6.01)	0.26 (0.20 to 0.34)
Anti-18C	15.23 (12.96 to 17.90)	0.07 (0.05 to 0.08)

Population analysed: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Primary outcome: Concentration of Antibody Against Protein D (PD)

Time frame: One month after primary immunization (month 3). Geometric mean (95% Confidence Interval). Unit: EL.U/mL

Measure	Synflorix and Tritanrix-HepB/Hib Group n = 227	Hiberix Group and Tritanrix-HepB Group n = 116
Value	2981.7 (2703.0 to 3289.2)	63.9 (55.8 to 73.1)

Population analysed: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Synflorix and Tritanrix-HepB/Hib Group	5 of 240 (2.1%)	231 of 240 (96.3%)	Not reported
Hiberix Group and Tritanrix-HepB Group	1 of 120 (0.8%)	114 of 120 (95%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22634448Lalwani S, Chatterjee S, Chhatwal J, Verghese VP, Mehta S, Shafi F, Borys D, Moreira M, Schuerman L. Immunogenicity, safety, and reactogenicity of the 10-valent pneumococcal non-typeable Hemophilus influenzae protein D conjugate vaccine (PHiD-CV) when co-administered with the DTPw-HBV/Hib vaccine in Indian infants: a single-blind, randomized, controlled study. Hum Vaccin Immunother. 2012 May;8(5):612-22. doi: 10.4161/hv.19287. Epub 2012 May 1.
Derived from this study: PubMed 25008901Lalwani S, Chatterjee S, Chhatwal J, Simon A, Ravula S, Francois N, Mehta S, Strezova A, Borys D. Randomized, open-label study of the impact of age on booster responses to the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in children in India. Clin Vaccine Immunol. 2014 Sep;21(9):1292-300. doi: 10.1128/CVI.00068-14. Epub 2014 Jul 9.
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. IPD is available via the Clinical Study Data Request site (click on the link provided below)

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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

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 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 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 29 Oct 2010). 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?

Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (time frame: One month after primary immunization (month 3)). The study lists 2 primary outcomes in all. 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 NCT00814710, 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 3 Jan 2020.