deltatrials
Completed PHASE3 INTERVENTIONAL 4-arm NCT00345358

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine

Evaluate Immunogenicity, Safety & Reactogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine Given as Catch-up Immunization in Children Older Than 7 mo of Age or as 3-dose Primary Immunization in Children Before 6 mo of Age

Sponsor: GlaxoSmithKline

Conditions Infections, Streptococcal
Interventions Infanrix IPV/Hib Synflorix
Updated 13 times since 2017 Last updated: Jul 20, 2018 Started: Sep 18, 2006 Primary completion: Nov 15, 2007 Completion: Nov 15, 2007
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Infections, Streptococcal, this trial is completed. The trial is conducted by GlaxoSmithKline and has accumulated 13 data snapshots since 2006. Infectious disease trials contribute critical data for public health response and treatment development.

Study Description(click to expand)

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

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

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshot~Jun 2018 – ~Feb 2019 · 8 months · monthly snapshot~Feb 2019 – ~Jan 2021 · 23 months · monthly snapshot~Jan 2021 – ~Jan 2022 · 12 months · monthly snapshot~Jan 2022 – ~Mar 2022 · 59 days · monthly snapshot~Mar 2022 – ~Jul 2024 · 28 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Feb 2026 · 5 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot~Feb 2026 – present · 2 months · monthly snapshot~Feb 2026 – present · 2 months · monthly snapshot

Change History

13 versions recorded

  1. Feb 2026 — Present [monthly]

    Completed PHASE3

  2. Feb 2026 — Present [monthly]

    Completed PHASE3

  3. Jan 2026 — Present [monthly]

    Completed PHASE3

  4. Sep 2025 — Feb 2026 [monthly]

    Completed PHASE3

  5. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

▶ Show 8 earlier versions

  1. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  2. Mar 2022 — Jul 2024 [monthly]

    Completed PHASE3

  3. Jan 2022 — Mar 2022 [monthly]

    Completed PHASE3

  4. Jan 2021 — Jan 2022 [monthly]

    Completed PHASE3

  5. Feb 2019 — Jan 2021 [monthly]

    Completed PHASE3

  6. Jun 2018 — Feb 2019 [monthly]

    Completed PHASE3

  7. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE3

  8. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

Sep 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • GlaxoSmithKline
Data source: GlaxoSmithKline

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations