Infections, StreptococcalPhase 3NCT00489554

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 12wks of Age

A Phase 3 study testing Synflorix, Infanrix hexa and Rotarix in people with Infections, Streptococcal and Streptococcus Pneumoniae Vaccines, run by GlaxoSmithKline at 2 sites in Mexico.

Completed

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

Official record

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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 Mexican infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a… Read more about this study

Who is it for?: Ages 6 to 12 weeksHealthy volunteers can take part
Conditions the study is for: Infections, Streptococcal, Streptococcus Pneumoniae Vaccines
What is being tested?: Synflorix, Infanrix hexa and Rotarix
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 230 participants
Where: 2 sitesMexico
Study dates: 3 Jul 2007to 31 Mar 2008
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 12 weeks
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Male or female subjects between and including 6-12 weeks of age at the time of the first vaccination.
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.
Born after a gestation period of 36 to 42 weeks inclusive.

Who cannot join

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccines and ending 7 days after dose 1 and dose 2 and one month after dose 3.
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.
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.

Show all 15Show fewer

Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, rotavirus and/or Streptococcus pneumoniae; with the exception of vaccines where the first dose may be given at birth within the first two weeks of life according to national recommendations (e.g. Hepatitis B and BCG).
History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b disease.
Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal (GI) tract, intussusception (IS) or other medical condition determined to be serious by the investigator.
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.

Trial locations and contacts

2 sites in 1 country.

Mexico2 sites

GSK Investigational Site
México, 14000
GSK Investigational Site
Mexico City, 14000

Other trials in Mexico

About this study

Official title: Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Infanrix Hexa and Rotarix

Read the detailed description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions: Infections, Streptococcal, Streptococcus Pneumoniae Vaccines
Being tested: Synflorix, Infanrix hexa, Rotarix
Keywords: Primary vaccination, Safety, Pneumococcal vaccine., Pneumococcal disease, 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.

SynflorixBiological
Also called Pneumococcal conjugate vaccine GSK1024850A.
Intramuscular injection, 3 doses.
Infanrix hexaBiological
Intramuscular injection, 3 doses.
RotarixBiological
Oral, 2 doses.

Study groups in NCT00489554
Study group	Role	What they receive
Synflorix Vaccine Group	Experimental	Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age. Receives: Biological: Synflorix; Biological: Infanrix hexa; Biological: Rotarix

What is being measured

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

Antibody Concentrations Against Pneumococcal Vaccine Serotypes
Concentrations were expressed as geometric mean concentration (GMC). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Measured: One month after the administration of the 3rd vaccine dose i.e. Month 5
Antibody Concentrations Against Protein D
Concentrations were given as geometric mean concentration (GMC) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter.
Measured: One month after the administration of the 3rd vaccine dose i.e. Month 5

Secondary outcomes (13)

Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes
The results were presented as the geometric mean dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Measured: One month after the administration of the 3rd vaccine dose i.e. Month 5
Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter
The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Measured: One month after the administration of the 3rd vaccine dose i.e. Month 5
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes
Antibody concentrations were expressed as Geometric Mean Concentrations against pneumococcal cross-reactive serotypes 6A and 19A.
Measured: One month after the administration of the 3rd vaccine dose i.e. Month 5
Opsonophagocytic Titer Against Pneumococcal Cross-reactive Serotypes
The results were presented as the geometric mean dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
Measured: One month after the administration of the 3rd vaccine dose i.e. Month 5
Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes
Seropositivity was defined as anti-pneumococcal antibody concentration greater than or equal to 0.05 microgram per milliliter. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Measured: One month after the administration of the 3rd vaccine dose i.e. Month 5
Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes
Seropositivity was defined as an opsonic titer greater than or equal to 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Measured: One month after the administration of the 3rd vaccine dose i.e. Month 5
Number of Subjects Seropositive Against Cross-reactive Pneumococcal Serotypes
Seropositivity was defined as anti-pneumococcal antibody concentration greater than or equal to 0.05 microgram per milliliter. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
Measured: One month after the administration of the 3rd vaccine dose i.e. Month 5
Number of Subjects Seropositive for Opsonic Titer Against Cross-reactive Pneumococcal Serotypes
Seropositivity was defined as anti-pneumococcal antibody opsonic titer greater than or equal to 8. The vaccine pneumococcal cross-reactive serotypes assessed include 6A and 19A.
Measured: One month after the administration of the 3rd vaccine dose i.e. Month 5
Number of Subjects Seropositive for Anti-Protein D Antibodies
Seropositivity was defined as antibody concentration greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter.
Measured: One month after the administration of the 3rd vaccine dose i.e. Month 5
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 redness and swelling was > 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. Any was occurrence of any local symptom regardless of grade and whatever the number of injections.
Measured: Within 4 days following any vaccine dose
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any fever was defined as axillary temperature ≥ 37.5 degree centigrade (°C), grade 3 fever was axillary temperature > 39.5°C. Grade 3 drowsiness, irritability, and loss of appetite was general symptom which prevented normal everyday activities. Grade 3 diarrhea was ≥ 6 looser than normal stools/day and Grade 3 vomiting was ≥ 3 episodes of vomiting/day. Related was solicited general symptom considered by the investigator to have a causal relationship to study vaccination.
Measured: Within 4 days following any vaccine dose
Number of Subjects Reporting Any Unsolicited AEs
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 after any vaccine dose
Number of Subjects Reporting Any 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: Up to Month 5

Timeline

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

3 Jul 200731 Mar 2008

First posted21 Jun 2007 (estimated)
Study start3 Jul 2007
Primary completion31 Mar 2008
Study completion31 Mar 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 (5)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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 230 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00489554
Sponsor's protocol ID: 109661
Other IDs: 2015-001510-10, 2015
Status last verified: Dec 2019
First submitted: 20 Jun 2007
Last updated: 13 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

Ruiz-Palacios G et al. Immunogenicity, safety and reactogenicity of the new 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) in Mexican infants. Abstract presented at the XIII Congreso Latinoamericano de Infectología Pediátrica (SLIPE). Guayaquil, Ecuador, 12-15 August 2009.
Ruiz-Palacios GM, Guerrero ML, Hernandez-Delgado L, Lavalle-Villalobos A, Casas-Munoz A, Cervantes-Apolinar Y, Moreira M, Schuerman L. Immunogenicity, reactogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Mexican infants. Hum Vaccin. 2011 Nov;7(11):1137-45. doi: 10.4161/hv.7.11.17984. Epub 2011 Nov 1.
PubMed 22048109
Schuerman L et al. Population variability in antibody responses following pneumococcal conjugate vaccination: experience with the non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Schuerman L et al. Population variability of opsonophagocytic activity following 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate (PHiD-CV) vaccination more limited than antibody responses. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Silfverdal SA, Coremans V, Francois N, Borys D, Cleerbout J. Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. 2017 Feb;16(2):109-121. doi: 10.1586/14760584.2016.1164044. Epub 2016 Sep 30.
PubMed 26954689

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 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Infanrix Hexa and Rotarix
ClinicalTrials.gov ID: NCT00489554
Acronym / sponsor ID: 109661
Conditions: Infections, Streptococcal, Streptococcus Pneumoniae Vaccines
Keywords: Primary vaccination, Safety, Pneumococcal vaccine., Pneumococcal disease, Immunogenicity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 230 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 3 Jul 2007 (actual)
Primary completion: 31 Mar 2008 (actual)
Study completion: 31 Mar 2008 (actual)
First posted: 21 Jun 2007 (estimated)
Results: Posted 10 May 2012

Clinical summary

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

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: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Synflorix Vaccine Group	Experimental	Biological: Synflorix, Biological: Infanrix hexa, Biological: RotarixSubjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.

Who may qualify

Ages: 6 to 12 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Male or female subjects between and including 6-12 weeks of age at the time of the first vaccination.
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.
Born after a gestation period of 36 to 42 weeks inclusive.

Key exclusion criteria (15 listed)

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccines and ending 7 days after dose 1 and dose 2 and one month after dose 3.
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.
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.

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
SynflorixAlso: Pneumococcal conjugate vaccine GSK1024850A.Intramuscular injection, 3 doses.	Biological	Synflorix Vaccine Group
Infanrix hexaIntramuscular injection, 3 doses.	Biological	Synflorix Vaccine Group
RotarixOral, 2 doses.	Biological	Synflorix Vaccine Group

Primary outcome

Antibody Concentrations Against Pneumococcal Vaccine Serotypes
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Concentrations were expressed as geometric mean concentration (GMC). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Antibody Concentrations Against Protein D
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Concentrations were given as geometric mean concentration (GMC) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter.

13 secondary outcomes

Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Opsonophagocytic Titer Against Pneumococcal Cross-reactive Serotypes
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Number of Subjects Seropositive Against Cross-reactive Pneumococcal Serotypes
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Number of Subjects Seropositive for Opsonic Titer Against Cross-reactive Pneumococcal Serotypes
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Number of Subjects Seropositive for Anti-Protein D Antibodies
Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Time frame: Within 4 days following any vaccine dose
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Time frame: Within 4 days following any vaccine dose
Number of Subjects Reporting Any Unsolicited AEs
Time frame: Within 31 days after any vaccine dose
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Time frame: Up to Month 5

Results and safety

Results posted to the registry on 10 May 2012, 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 Vaccine Group	230	226

Primary outcome: Antibody Concentrations Against Pneumococcal Vaccine Serotypes

Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5. Geometric mean (95% Confidence Interval). Unit: microgram per milliliter

Measure	Synflorix Vaccine Group n = 219
Anti-1 antibody (N=219)	2.13 (1.94 to 2.34)
Anti-4 antibody (N=218)	3.04 (2.77 to 3.34)
Anti-5 antibody (N=218)	3.24 (2.97 to 3.53)
Anti-6B antibody (N=218)	1.32 (1.14 to 1.54)
Anti-7F antibody (N=218)	3.72 (3.40 to 4.07)
Anti-9V antibody (N=218)	3.71 (3.37 to 4.09)
Anti-14 antibody (N=218)	5.27 (4.66 to 5.96)
Anti-18C antibody (N=219)	6.05 (5.30 to 6.89)

Population analysed: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.

Primary outcome: Antibody Concentrations Against Protein D

Time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5. Geometric mean (95% Confidence Interval). Unit: ELISA units per milliliter

Measure	Synflorix Vaccine Group n = 219
Value	2923.2 (2588.6 to 3301.1)

Population analysed: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Synflorix Vaccine Group	15 of 230 (6.5%)	229 of 230 (99.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundRuiz-Palacios G et al. Immunogenicity, safety and reactogenicity of the new 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) in Mexican infants. Abstract presented at the XIII Congreso Latinoamericano de Infectología Pediátrica (SLIPE). Guayaquil, Ecuador, 12-15 August 2009.
Background: PubMed 22048109Ruiz-Palacios GM, Guerrero ML, Hernandez-Delgado L, Lavalle-Villalobos A, Casas-Munoz A, Cervantes-Apolinar Y, Moreira M, Schuerman L. Immunogenicity, reactogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Mexican infants. Hum Vaccin. 2011 Nov;7(11):1137-45. doi: 10.4161/hv.7.11.17984. Epub 2011 Nov 1.
BackgroundSchuerman L et al. Population variability in antibody responses following pneumococcal conjugate vaccination: experience with the non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
BackgroundSchuerman L et al. Population variability of opsonophagocytic activity following 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate (PHiD-CV) vaccination more limited than antibody responses. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Background: PubMed 26954689Silfverdal SA, Coremans V, Francois N, Borys D, Cleerbout J. Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. 2017 Feb;16(2):109-121. doi: 10.1586/14760584.2016.1164044. Epub 2016 Sep 30.
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Synflorix, Infanrix hexa and Rotarix in people with Infections, Streptococcal and Streptococcus Pneumoniae Vaccines, run by GlaxoSmithKline at 2 sites in Mexico.

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 15 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 13 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 2 sites in Mexico. 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 10 May 2012). 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?

Antibody Concentrations Against Pneumococcal Vaccine Serotypes (time frame: One month after the administration of the 3rd vaccine dose i.e. Month 5). 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 NCT00489554, which also lists 5 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 13 Jan 2020.