Infections, StreptococcalPhase 3NCT00808444

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

A Phase 3 study testing Pneumococcal conjugate vaccine GSK1024850A (different lots), Infanrix hexa and Infanrix-IPV/Hib in people with Infections, Streptococcal, run by GlaxoSmithKline at 5 sites in 2 countries.

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 the present study is to demonstrate that the changes in the manufacturing process for the commercial lot of the pneumococcal conjugate vaccine GSK1024850A have no clinical impact and that the immune responses are non-inferior to the immune responses induced by the clinical lot. 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
What is being tested?: Pneumococcal conjugate vaccine GSK1024850A (different lots), Infanrix hexa and Infanrix-IPV/Hib
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: 466 participants
Where: 5 sitesin 2 countries
Study dates: 5 Jan 2009to 2 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 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 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.
Free of any known or suspected 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.

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.
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 15Show fewer

Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of vaccines where the first dose can be given within the first two weeks of life).
Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 7 days after Dose 1 and Dose 2 and 30 days after Dose 3.
History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, H. influenzae type b and rotavirus 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.
Gastroenteritis within 7 days preceding the study vaccine administration.
Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator.

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

Singapore3 sites

GSK Investigational Site
Singapore, 119074
GSK Investigational Site
Singapore, 149547
GSK Investigational Site
Singapore, 229899

Other trials in Singapore

Malaysia2 sites

GSK Investigational Site
Kuala Lumpur, 59100
GSK Investigational Site
Seremban, Negeri Sembilan, 70300

Other trials in Malaysia

About this study

Official title: Non-inferiority of a Commercial Lot of the Pneumococcal Vaccine GSK1024850A Compared to a Clinical Lot.

Conditions: Infections, Streptococcal
Being tested: Pneumococcal conjugate vaccine GSK1024850A (different lots), Infanrix hexa, Infanrix-IPV/Hib, Rotarix
Keywords: Pneumococcal vaccine, Immunogenicity, Primary vaccination, Safety, Pneumococcal disease
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 GSK1024850A (different lots)Biological
Intramuscular injection, 3 doses
Infanrix hexaBiological
Also called DTPa-combined vaccine
Intramuscular injection, 3 doses in Malaysia and 2 doses in Singapore
Infanrix-IPV/HibBiological
Also called DTPa-combined vaccine
Intramuscular injection, only for Visit 2 in Singapore
RotarixBiological
Also called HRV vaccine
Oral, 2 doses

Study groups in NCT00808444
Study group	Role	What they receive
Synflorix Clinical Lot & Infanrix Group	Experimental	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1). Receives: Biological: Pneumococcal conjugate vaccine GSK1024850A (different lots); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib; Biological: Rotarix
Synflorix Commercial Lot Infanrix Group	Experimental	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1). Receives: Biological: Pneumococcal conjugate vaccine GSK1024850A (different lots); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib; Biological: Rotarix

What is being measured

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

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

Secondary outcomes (15)

Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL
Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Measured: One month after primary immunization (month 4)
Number of Subjects With Anti-pneumococcal Cross-reactive Serotype Concentrations Equal to or Above 0.20 µg/mL
Anti-pneumococcal cross-reactive serotypes were 6A and 19A.
Measured: One month after primary immunization (month 4)
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
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 4)
Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes
Cross-reactive pneumococcal serotypes were 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 4)
Opsonophagocytic Titers of Cross-reactive Pneumococcal Serotypes
Opsonophagocytic titers were expressed as GMTs.
Cross-reactive pneumococcal serotypes included 6A and 19A.
Measured: One month after primary immunization (month 4)
Poliovirus Types 1, 2 and 3 Titers
Titers were given as Geometric Mean Titers (GMTs).
Measured: One month after primary immunization (month 4)
Concentrations of Antibodies Against Diphteria Toxoid (DT) and Tetanus Toxoid (TT)
Concentrations were defined as GMCs in international units per milliter (IU/mL)
Measured: One month after primary immunization (month 4)
Concentration of Antibody Against Hepatitis B Surface Antigen (HBs) by Enzyme Linked ImmunoSorbent Assay (ELISA).
Concentration was given as GMC in milli international units per milliliter (mIU/mL). As a decrease in the specificity of the anti-HB 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 reanalysis.
Measured: One month after primary immunization (month 4)
Concentration of Antibody Against Rotavirus Immunoglobulin A (IgA)
Concentration was expressed as GMC in units per milliliter (U/mL).
Measured: 3 months after primary immunization (month 4)
Occurrence of Serious Adverse Events
SAEs assessed include medical occurrences that result in death, is 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 vaccination and throughout the entire study period (Month 0 to Month 4)
Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes
Titers are presented as Geometric Mean Titers (GMTs).
Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Measured: One month after primary immunization (month 4)
Number of Subjects With Solicited Local and General Symptoms.
Solicited local symptoms were pain, redness and swelling.
Solicited general symptoms were drowsiness, fever, irritability, loss of appetite, diarrhoea and vomiting.
Measured: Within 4 days (day 0-3) after vaccination
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)
Concentrations are expressed as GMCs in EL.U/mL.
Measured: One month after primary immunization (month 4)
Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)
Concentrain was expressed as GMC in µg/mL.
Measured: One month after primary immunization (month 4)
Occurrence of Unsolicited Adverse Events
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.
Measured: Within 31 days (day 0-30) after vaccination

Timeline

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

5 Jan 20092 Nov 2009

First posted15 Dec 2008 (estimated)
Study start5 Jan 2009
Primary completion2 Nov 2009
Study completion2 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 (1)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: Double blind
Who is masked: Care provider, Outcomes assessor
Enrolment: 466 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00808444
Sponsor's protocol ID: 111654
Status last verified: Oct 2016
First submitted: 11 Dec 2008
Last updated: 17 Aug 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

Lim FS, Koh MT, Tan KK, Chan PC, Chong CY, Shung Yehudi YW, Teoh YL, Shafi F, Hezareh M, Swinnen K, Borys D. A randomised trial to evaluate the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Singapore and Malaysia. BMC Infect Dis. 2014 Oct 2;14:530. doi: 10.1186/1471-2334-14-530.
PubMed 25278086

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?

See locations

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All Infections, Streptococcal trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-inferiority of a Commercial Lot of the Pneumococcal Vaccine GSK1024850A Compared to a Clinical Lot.
ClinicalTrials.gov ID: NCT00808444
Acronym / sponsor ID: 111654
Conditions: Infections, Streptococcal
Keywords: Pneumococcal vaccine, Immunogenicity, Primary vaccination, Safety, Pneumococcal disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 466 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 5 Jan 2009
Primary completion: 2 Nov 2009 (actual)
Study completion: 2 Nov 2009 (actual)
First posted: 15 Dec 2008 (estimated)
Results: Posted 19 Nov 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: Double blind (care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Synflorix Clinical Lot & Infanrix Group	Experimental	Biological: Pneumococcal conjugate vaccine GSK1024850A (different lots), Biological: Infanrix hexa, Biological: Infanrix-IPV/Hib, Biological: RotarixSubjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
Synflorix Commercial Lot Infanrix Group	Experimental	Biological: Pneumococcal conjugate vaccine GSK1024850A (different lots), Biological: Infanrix hexa, Biological: Infanrix-IPV/Hib, Biological: RotarixSubjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

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 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.
Free of any known or suspected 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.

Key exclusion criteria (15 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.
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 GSK1024850A (different lots)Intramuscular injection, 3 doses	Biological	Synflorix Clinical Lot & Infanrix Group, Synflorix Commercial Lot Infanrix Group
Infanrix hexaAlso: DTPa-combined vaccineIntramuscular injection, 3 doses in Malaysia and 2 doses in Singapore	Biological	Synflorix Clinical Lot & Infanrix Group, Synflorix Commercial Lot Infanrix Group
Infanrix-IPV/HibAlso: DTPa-combined vaccineIntramuscular injection, only for Visit 2 in Singapore	Biological	Synflorix Clinical Lot & Infanrix Group, Synflorix Commercial Lot Infanrix Group
RotarixAlso: HRV vaccineOral, 2 doses	Biological	Synflorix Clinical Lot & Infanrix Group, Synflorix Commercial Lot Infanrix Group

Primary outcome

Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine
Time frame: One month after primary immunization (month 4)
Concentrations are given as Geometric Mean Concentrations (GMCs) in microgram per milliliter (μg/mL). Vaccine pneumococcal serotypes assessed 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 4)
Concentration was expressed as GMC in GSK's 22F enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

15 secondary outcomes

Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL
Time frame: One month after primary immunization (month 4)
Number of Subjects With Anti-pneumococcal Cross-reactive Serotype Concentrations Equal to or Above 0.20 µg/mL
Time frame: One month after primary immunization (month 4)
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Time frame: One month after primary immunization (month 4)
Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes
Time frame: One month after primary immunization (month 4)
Opsonophagocytic Titers of Cross-reactive Pneumococcal Serotypes
Time frame: One month after primary immunization (month 4)
Poliovirus Types 1, 2 and 3 Titers
Time frame: One month after primary immunization (month 4)
Concentrations of Antibodies Against Diphteria Toxoid (DT) and Tetanus Toxoid (TT)
Time frame: One month after primary immunization (month 4)
Concentration of Antibody Against Hepatitis B Surface Antigen (HBs) by Enzyme Linked ImmunoSorbent Assay (ELISA).
Time frame: One month after primary immunization (month 4)
Concentration of Antibody Against Rotavirus Immunoglobulin A (IgA)
Time frame: 3 months after primary immunization (month 4)
Occurrence of Serious Adverse Events
Time frame: Following vaccination and throughout the entire study period (Month 0 to Month 4)
Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes
Time frame: One month after primary immunization (month 4)
Number of Subjects With Solicited Local and General Symptoms.
Time frame: Within 4 days (day 0-3) after vaccination
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)
Time frame: One month after primary immunization (month 4)
Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)
Time frame: One month after primary immunization (month 4)
Occurrence of Unsolicited Adverse Events
Time frame: Within 31 days (day 0-30) after vaccination

Results and safety

Results posted to the registry on 19 Nov 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 Clinical Lot & Infanrix Group	233	232
Synflorix Commercial Lot & Infanrix Group	233	232

Primary outcome: Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine

Time frame: One month after primary immunization (month 4). Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	Synflorix Clinical Lot & Infanrix Group n = 219	Synflorix Commercial Lot & Infanrix Group n = 218
Anti-1	2.67 (2.46 to 2.91)	2.46 (2.25 to 2.69)
Anti-4	3.95 (3.59 to 4.36)	3.14 (2.84 to 3.47)
Anti-5	4.34 (3.95 to 4.76)	3.59 (3.29 to 3.92)
Anti-6B	1.31 (1.16 to 1.48)	1.23 (1.07 to 1.41)
Anti-7	3.10 (2.83 to 3.39)	3.20 (2.92 to 3.51)
Anti-9V	3.34 (3.03 to 3.69)	3.14 (2.83 to 3.49)
Anti-14	5.13 (4.54 to 5.79)	4.74 (4.23 to 5.32)
Anti-18C	5.00 (4.40 to 5.69)	5.15 (4.43 to 5.97)

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

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

Time frame: One month after primary immunization (month 4). Geometric mean (95% Confidence Interval). Unit: EL.U/mL

Measure	Synflorix Clinical Lot & Infanrix Group n = 219	Synflorix Commercial Lot & Infanrix Group n = 218
Value	2543.6 (2319.4 to 2789.4)	1869.8 (1671.2 to 2091.9)

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

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Frequent AEs were assessed during the 4-day (day 0-3) follow-up period after vaccination for solicited AEs and 31-day (day 0-30) follow-up period for unsolicited AEs. SAEs were assessed from month 0 until study end (month 4).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Synflorix Clinical Lot & Infanrix Group	18 of 233 (7.7%)	230 of 233 (98.7%)	Not reported
Synflorix Commercial Lot & Infanrix Group	7 of 233 (3%)	228 of 233 (97.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25278086Lim FS, Koh MT, Tan KK, Chan PC, Chong CY, Shung Yehudi YW, Teoh YL, Shafi F, Hezareh M, Swinnen K, Borys D. A randomised trial to evaluate the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Singapore and Malaysia. BMC Infect Dis. 2014 Oct 2;14:530. doi: 10.1186/1471-2334-14-530.
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

5 sites in 2 countries: 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 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 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Singapore, Malaysia. 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 19 Nov 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 Components of the Pneumococcal Vaccine (time frame: One month after primary immunization (month 4)). 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 NCT00808444, which also lists 1 linked publication.

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 17 Aug 2018.