NCT02052154

Brief Summary

Evaluate the immunogenicity of an innovative pneumococcal vaccination strategy in splenectomized adults comprising 1 dose of Prevenar13® conjugate vaccine (PCV) at M0 followed by 1 dose of Pneumo23® or Pneumovax® polysaccharide vaccine (PPSV) at M2. Duration of follow-up of 36 months. The main endpoint will be the proportion of subjects responsive to 9 of the 13 serotypes common to the PCV and PPSV vaccines, selected because of their frequency in invasive infections in adults in France and their potentially reduced susceptibility to penicillin (serotypes 1, 3, 6A, 7F, 9V, 14, 19A, 19F, 23F).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 10, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2016

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2019

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

2.4 years

First QC Date

January 20, 2014

Last Update Submit

November 17, 2025

Conditions

Splenectomized Patients

Keywords

Pneumococcal infectionSplenectomizedvaccination

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects responsive to 9 of the 13 serotypes common (serotypes 1, 3, 6A, 7F, 9V, 14, 19A, 19F, 23F).

    According to currently accepted international guidelines, a subject is considered to be responsive to a given serotype if one month after PPSV vaccination (at M3) the specific IgG titer is ≥ 1 μg/mL by ELISA and the opsonophagocytosis assay (OPA) threshold response is ≥ at LLOQ (Lower limit of quantification)

    M3

Secondary Outcomes (10)

  • IgG dosage

    one month

  • ELISA dosages

    4 months after PPSV vaccine

  • ELISA dosages

    10 months after PPSV vaccine

  • ELISA dosages

    34 months after PPSV vaccine

  • Identification of predictive factors for immunogenicity

    M0 to M36

  • +5 more secondary outcomes

Study Arms (1)

Prime-boost pneumococcal immunization

EXPERIMENTAL
Biological: Prime-boost pneumococcal immunization

Interventions

Prime-boost pneumococcal immunizationBIOLOGICAL

2 months between the 2 vaccines

Also known as: Prevenar13® followed by Pneumo23®
Prime-boost pneumococcal immunization

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years and ≤ 75 years
  • Splenectomized since at least 2 weeks, with Howell-Jolly bodies on a blood smear and ultrasonographic confirmation
  • No immunosppressived conditions : mainly trauma , idiopathic thrombocytopathic purpura or autoimmune hemolytic anemia, with no active treatment
  • Available for 37 months of follow-up starting from the screening visit
  • Contraception that the investigator judges effective for the first 2 months of the trial, with a negative pregnancy test
  • Signed informed consent

You may not qualify if:

  • History of anaphylactic reaction following vaccination
  • Known allergy to any of the ingredients of the vaccines: aluminium phosphate, phenol, Corynebacterium diphtheriae CRM-197 protein
  • Previous vaccination with 7-valent or 13-valent pneumococcal conjugate vaccine (in the 5 last years)
  • Not covered by national health insurance (beneficiary or assignee)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service des Maladies Infectieuses et Tropicales - Centre d'Infectiologie Necker-Pasteur, IHU Imagine - Hôpital Necker-Enfants

Paris, 75015, France

Location

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Hélène COIGNARD-BIEHLER, MD

    Service des Maladies Infectieuses et Tropicales, Hôpital Necker-Enfants Malades, APHP

    PRINCIPAL INVESTIGATOR

  • Olivier LORTHOLARY, MD, PhD

    Service des Maladies Infectieuses et Tropicales, Hôpital Necker-Enfants Malades, APHP

    STUDY DIRECTOR

  • Odile LAUNAY, MD, PhD

    CIC Vaccinologie Cochin-Pasteur (CIC BT505) - Hôpital Cochin

    STUDY DIRECTOR

  • Marc MICHEL, MD, PhD

    Service de médecine interne, Hôpital Henri Mondor

    STUDY DIRECTOR

  • Frédéric BATTEUX, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY CHAIR

  • Claude-Agnès REYNAUD, PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    STUDY CHAIR

  • Pierre BUFFET, MD, PhD

    INTS

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2014

First Posted

January 31, 2014

Study Start

March 10, 2014

Primary Completion

July 19, 2016

Study Completion

April 2, 2019

Last Updated

November 20, 2025

Record last verified: 2025-10

Locations

FR(1)