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CompletedNCT00533507Updated Jun 8, 2018Results posted

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age

A Phase 3 interventional study of Synflorix and Infanrix hexa in Infections, Rotavirus, sponsored by GlaxoSmithKline. Completed at 3 sites in Taiwan. Open to participants aged 6 Weeks to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-08.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
230
Allocation
Non-randomized
Ages
6 Weeks to 8 Weeks
Sex
All
01

Study 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 Taiwanese infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined vaccine and rotavirus vaccine in children during the first 6 months of life.

Read the detailed description

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

02

Conditions studied

  • Infections, Rotavirus

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Keywords

  • Pneumococcal vaccine.
  • Pneumococcal disease
  • Safety
  • Immunogenicity
  • Primary vaccination
03

In context

Rotavirus Infections

101 studies on the registry are indexed under Rotavirus Infections; 3 are open to participants now.

This study's enrollment of 230 is below the median of 402 across 68 interventional studies indexed under Rotavirus Infections.

Browse Rotavirus Infections studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Weeks to 8 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male or female subjects between, and including 6-8 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 informed consent obtained from the parent(s) or guardian(s) 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
  • 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 within the first two weeks of life according to the national recommendations (e.g. Hepatitis B and Bacillus Calmette-Guérin (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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
230 participants (actual)

Study arms

  • Experimental
    Synflorix group

    Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.

    Biological: Synflorix · Biological: Infanrix hexa · Biological: Rotarix

Interventions

  • BiologicalSynflorix

    Intramuscular injection, 3 doses.

    Also known as: Pneumococcal conjugate vaccine GSK1024850A

  • BiologicalInfanrix hexa

    Intramuscular injection, 3 doses.

    Also known as: DTPa-HBV-IPV/Hib

  • BiologicalRotarix

    Oral, 2 doses.

    Also known as: HRV vaccine

06

What researchers measure

Primary outcomes

  1. Concentration of Anti-Protein D Antibodies

    Concentrations are given as geometric mean concentrations (GMC) and expressed in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).

    Time frame: One month after the third dose

  2. Concentration of Anti-Pneumococcal Antibodies

    Concentrations are given as geometric mean titers (GMC) and expressed in microgram per milliliter (µg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

    Time frame: One month after the third dose

Secondary outcomes

  1. Number of Subjects With Anti-Protein D Antibody Concentrations Above the Cut-Off Value

    Anti-protein D antibody cut-off value assessed was greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).

    Time frame: Before the first dose (pre) and one month after (post) the third dose

  2. Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value

    Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

    Time frame: Before the first dose (pre) and one month after (post) the third dose

  3. Number of Subjects With Cross-Reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value

    Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL).

    Time frame: One month after the third dose

  4. 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 greater than or equal to 1:8 titer.

    Time frame: One month after the third dose

  5. Number of Subjects With Opsonophagocytic Activity Against Cross-Reactive Pneumococcal Serotypes Above the Cut-Off Value

    Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer.

    Time frame: One month after the third dose

  6. Number of Subjects With Anti-Polyribosyl-Ribitol Phosphate Antibody Concentrations Above the Cut-Off Value

    Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was greater than or equal to 0.15 microgram per milliliter (μg/mL).

    Time frame: One month after the third dose

  7. Number of Subjects With Anti-Diphteria and Anti-Tetanus Toxoids Antibody Concentrations Above the Cut-Off Value

    Anti-diphteria and anti-tetanus toxoids antibody cut-off values assessed were greater than or equal to 0.10 International Units per milliliter (IU/mL).

    Time frame: One month after the third dose

  8. Number of Subjects With Anti-Pertussis (PT), Anti-Filamentous Hemagglutinin (FHA) and Anti-Pertactin (PRN) Antibody Concentrations Above the Cut-Off Value

    Anti-PT, anti-FHA and anti-PRN cut-off values assessed were greater than or equal to 5 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).

    Time frame: One month after the third dose

  9. Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value

    Anti-HBs antibody cut-off value assessed was greater than or equal to 10 milli-International Units per milliliter (mIU/mL).

    Time frame: One month after the third dose

  10. Number of Subjects With Anti-Poliovirus 1, 2 and 3 Antibody Titers Above the Cut-Off Value

    Anti-poliovirus 1, 2 and 3 antibody cut-off value assessed was greater than or equal to 1:8 titer.

    Time frame: One month after the third dose

  11. Number of Subjects With Anti-rotavirus Immunoglobulin A Antibody Concentrations Above the Cut-Off Value

    Anti-rotavirus IgA antibody cut-off value assessed was greater than or equal to 20 Units per milliliter (U/mL).

    Time frame: Four months after the administration of the second dose of Rotarix™ vaccine

  12. Number of Subjects Reporting Solicited Symptoms

    Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include diarrhoea, drowsiness, fever, irritability, loss of appetite, and vomiting

    Time frame: During the 4-day (Day 0-3) period after each dose

  13. Number of Subjects Reporting Unsolicited Adverse Events (AE)

    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

    Time frame: During the 31-day (Day 0-30) period after each dose

  14. Number of Subjects Reporting Serious Adverse Events (SAE)

    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.

    Time frame: Up to one month after the third dose

07

Results

Posted Jul 24, 2009

Participant flow

Participant flow — Overall Study
MilestoneSynflorix Group
Started230
Completed229
Not completed1
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryConcentration of Anti-Protein D Antibodies

Concentrations are given as geometric mean concentrations (GMC) and expressed in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).

Time frame:
One month after the third dose
Reported as:
Geometric mean · EL.U/mL
Concentration of Anti-Protein D Antibodies
EL.U/mLSynflorix Group
Concentration of Anti-Protein D Antibodies2277.6 (2048.7 to 2532.1)
PrimaryConcentration of Anti-Pneumococcal Antibodies

Concentrations are given as geometric mean titers (GMC) and expressed in microgram per milliliter (µg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

Time frame:
One month after the third dose
Reported as:
Geometric mean · µg/mL
Concentration of Anti-Pneumococcal Antibodies
µg/mLSynflorix Group
Anti-12.92 (2.65 to 3.22)
Anti-43.79 (3.42 to 4.19)
Anti-54.50 (4.11 to 4.93)
Anti-6B1.69 (1.47 to 1.94)
Anti-7F4.07 (3.72 to 4.46)
Anti-9V3.90 (3.51 to 4.32)
Anti-145.69 (5.10 to 6.35)
Anti-18C7.28 (6.43 to 8.25)
Anti-19F8.04 (7.37 to 8.78)
Anti-23F2.81 (2.44 to 3.22)
SecondaryNumber of Subjects With Anti-Protein D Antibody Concentrations Above the Cut-Off Value

Anti-protein D antibody cut-off value assessed was greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).

Time frame:
Before the first dose (pre) and one month after (post) the third dose
Reported as:
Number · subjects
Number of Subjects With Anti-Protein D Antibody Concentrations Above the Cut-Off Value
subjectsSynflorix Group
Pre (N=217)38
Post (N=219)218
SecondaryNumber of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value

Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

Time frame:
Before the first dose (pre) and one month after (post) the third dose
Reported as:
Number · subjects
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value
subjectsSynflorix Group
Anti-1 Pre (N=217)111
Anti-1 Post (N=219)219
Anti-4 Pre (N=217)85
Anti-4 Post (N=219)219
Anti-5 Pre (N=217)149
Anti-5 Post (N=219)219
Anti-6B Pre (N=217)107
Anti-6B Post (N=219)215
Anti-7F Pre (N=218)138
Anti-7F Post (N=219)219
Anti-9V Pre (N=218)123
Anti-9V Post (N=219)219
Anti-14 Pre (N=218)203
Anti-14 Post (N=219)219
Anti-18C Pre (N=219)153
Anti-18C Post (N=219)219
Anti-19F Pre (N=219)172
Anti-19F Post (N=219)219
Anti-23F Pre (N=219)91
Anti-23F Post (N=219)216
SecondaryNumber of Subjects With Cross-Reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value

Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL).

Time frame:
One month after the third dose
Reported as:
Number · subjects
Number of Subjects With Cross-Reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value
subjectsSynflorix Group
Anti-6A (N=219)210
Anti-19A (N=218)200
SecondaryNumber 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 greater than or equal to 1:8 titer.

Time frame:
One month after the third dose
Reported as:
Number · subjects
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value
subjectsSynflorix Group
Opsono-1 (N=102)98
Opsono-4 (N=103)103
Opsono-5 (N=102)101
Opsono-6B (N=102)89
Opsono-7F (N=103)103
Opsono-9V (N=98)98
Opsono-14 (N=102)101
Opsono-18C (N=101)99
Opsono-19F (N=103)101
Opsono-23F (N=102)98
SecondaryNumber of Subjects With Opsonophagocytic Activity Against Cross-Reactive Pneumococcal Serotypes Above the Cut-Off Value

Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer.

Time frame:
One month after the third dose
Reported as:
Number · subjects
Number of Subjects With Opsonophagocytic Activity Against Cross-Reactive Pneumococcal Serotypes Above the Cut-Off Value
subjectsSynflorix Group
Opsono-6A87
Opsono-19A38
SecondaryNumber of Subjects With Anti-Polyribosyl-Ribitol Phosphate Antibody Concentrations Above the Cut-Off Value

Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was greater than or equal to 0.15 microgram per milliliter (μg/mL).

Time frame:
One month after the third dose
Reported as:
Number · subjects
Number of Subjects With Anti-Polyribosyl-Ribitol Phosphate Antibody Concentrations Above the Cut-Off Value
subjectsSynflorix Group
Number of Subjects With Anti-Polyribosyl-Ribitol Phosphate Antibody Concentrations Above the Cut-Off Value58
SecondaryNumber of Subjects With Anti-Diphteria and Anti-Tetanus Toxoids Antibody Concentrations Above the Cut-Off Value

Anti-diphteria and anti-tetanus toxoids antibody cut-off values assessed were greater than or equal to 0.10 International Units per milliliter (IU/mL).

Time frame:
One month after the third dose
Reported as:
Number · subjects
Number of Subjects With Anti-Diphteria and Anti-Tetanus Toxoids Antibody Concentrations Above the Cut-Off Value
subjectsSynflorix Group
Anti-diphteria toxoid58
Anti-tetanus toxoid58
SecondaryNumber of Subjects With Anti-Pertussis (PT), Anti-Filamentous Hemagglutinin (FHA) and Anti-Pertactin (PRN) Antibody Concentrations Above the Cut-Off Value

Anti-PT, anti-FHA and anti-PRN cut-off values assessed were greater than or equal to 5 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).

Time frame:
One month after the third dose
Reported as:
Number · subjects
Number of Subjects With Anti-Pertussis (PT), Anti-Filamentous Hemagglutinin (FHA) and Anti-Pertactin (PRN) Antibody Concentrations Above the Cut-Off Value
subjectsSynflorix Group
Anti-PT (N=58)58
Anti-FHA (N=58)58
Anti-PRN (N=57)57
SecondaryNumber of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value

Anti-HBs antibody cut-off value assessed was greater than or equal to 10 milli-International Units per milliliter (mIU/mL).

Time frame:
One month after the third dose
Reported as:
Number · subjects
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value
subjectsSynflorix Group
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value32
SecondaryNumber of Subjects With Anti-Poliovirus 1, 2 and 3 Antibody Titers Above the Cut-Off Value

Anti-poliovirus 1, 2 and 3 antibody cut-off value assessed was greater than or equal to 1:8 titer.

Time frame:
One month after the third dose
Reported as:
Number · subjects
Number of Subjects With Anti-Poliovirus 1, 2 and 3 Antibody Titers Above the Cut-Off Value
subjectsSynflorix Group
Anti-poliovirus 144
Anti-poliovirus 244
Anti-poliovirus 344
SecondaryNumber of Subjects With Anti-rotavirus Immunoglobulin A Antibody Concentrations Above the Cut-Off Value

Anti-rotavirus IgA antibody cut-off value assessed was greater than or equal to 20 Units per milliliter (U/mL).

Time frame:
Four months after the administration of the second dose of Rotarix™ vaccine
Reported as:
Number · subjects
Number of Subjects With Anti-rotavirus Immunoglobulin A Antibody Concentrations Above the Cut-Off Value
subjectsSynflorix Group
Number of Subjects With Anti-rotavirus Immunoglobulin A Antibody Concentrations Above the Cut-Off Value44
SecondaryNumber of Subjects Reporting Solicited Symptoms

Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include diarrhoea, drowsiness, fever, irritability, loss of appetite, and vomiting

Time frame:
During the 4-day (Day 0-3) period after each dose
Reported as:
Number · subjects
Number of Subjects Reporting Solicited Symptoms
subjectsSynflorix Group
Pain146
Redness144
Swelling139
Diarrhoea7
Drowsiness190
Fever153
Irritability203
Loss of appetite159
Vomiting55
SecondaryNumber of Subjects Reporting Unsolicited Adverse Events (AE)

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

Time frame:
During the 31-day (Day 0-30) period after each dose
Reported as:
Number · subjects
Number of Subjects Reporting Unsolicited Adverse Events (AE)
subjectsSynflorix Group
Number of Subjects Reporting Unsolicited Adverse Events (AE)95
SecondaryNumber of Subjects Reporting Serious Adverse Events (SAE)

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.

Time frame:
Up to one month after the third dose
Reported as:
Number · subjects
Number of Subjects Reporting Serious Adverse Events (SAE)
subjectsSynflorix Group
Number of Subjects Reporting Serious Adverse Events (SAE)15

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Synflorix Group——224/230 (97.4%)
Most frequent serious events
Showing 10 of 15
Most frequent serious events
EventSynflorix Group
Urinary tract infectionInfections and infestations6/230
BronchiolitisInfections and infestations4/230
GastroenteritisInfections and infestations2/230
PyrexiaGeneral disorders2/230
Bronchial hyperreactivityRespiratory, thoracic and mediastinal disorders1/230
BronchopneumoniaInfections and infestations1/230
DehydrationMetabolism and nutrition disorders1/230
Dermatitis atopicSkin and subcutaneous tissue disorders1/230
Dermatitis diaperSkin and subcutaneous tissue disorders1/230
EnterocolitisGastrointestinal disorders1/230
Most frequent other events
Most frequent other events
EventSynflorix Group
IrritabilityGeneral disorders203/230
DrowsinessGeneral disorders190/230
Loss of appetiteGeneral disorders159/230
FeverGeneral disorders153/230
PainGeneral disorders146/230
RednessGeneral disorders144/230
SwellingGeneral disorders139/230
VomitingGeneral disorders55/230
Upper respiratory tract infectionInfections and infestations54/230

Baseline characteristics

Age, Continuous
Age, Continuous(weeks)Synflorix Group
Mean6.4 ± 0.60
Sex: Female, Male
Sex: Female, Male(Participants)Synflorix Group
Female115
Male115
08

Study locations

3 sites
  • GSK Investigational Site
    Taipei, 100, Taiwan
  • GSK Investigational Site
    Taipei, 105, Taiwan
  • GSK Investigational Site
    Taoyuan Hsien, Taiwan
09

References and documents

Publications

  • Lin TY, Lu CY, Chang LY, Chiu CH, Huang YC, Bock HL, Tang H, Francois N, Moreira M, Schuerman L, Huang LM. Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Taiwan. J Formos Med Assoc. 2012 Sep;111(9):495-503. doi: 10.1016/j.jfma.2011.07.014. Epub 2012 Mar 18. PubMed 23021506 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00533507
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 21, 2007
Start date
Sep 18, 2007
Primary completion
Jun 1, 2008
Completion
Jun 6, 2008
Results posted
Jul 24, 2009
Last update
Jun 8, 2018

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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