Whooping Cough

• EMA approval · 2026-08-07
  EMA Authorised: Hexacima (hepatitis B surface antigen;Diphtheria toxoid;Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin;poliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett);Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein;tetanus toxoid) — Sanofi Winthrop Industrie

  EMA authorised Hexacima, a combination vaccine covering hepatitis B, diphtheria, pertussis, poliomyelitis, Haemophilus influenzae type b, te…

• EMA approval · 2026-08-07
  EMA Authorised: Hexyon (filamentous haemagglutinin;Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate);hepatitis B surface antigen;pertussis toxoid;poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells;poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells;poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells;tetanus protein;tetanus toxoid adsorbed on aluminium hydroxide, hydrated;Diphtheria toxoid) — Sanofi Winthrop Industrie

  EMA has authorised Hexyon, a combined immunization vaccine covering multiple diseases including hepatitis B, diphtheria, tetanus, pertussis,…

• EMA approval · 2026-07-10
  EMA Authorised: Infanrix Hexa (Diphtheria toxoid;tetanus toxoid;Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin);hepatitis B surface antigen;poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain));Haemophilus influenzae type b polysaccharide) — GlaxoSmithKline Biologicals S.A.

  EMA has authorised Infanrix Hexa, a hexavalent vaccine by GlaxoSmithKline Biologicals S.A., covering multiple antigens including diphtheria,…

• CLINICAL_TRIALS trial_result · 2023-06-27
  Clinical Trial Update: Study of BPZE1 Intranasal Pertussis Vaccine (Administered Via VaxINator(TM)), Prime + Boost, in Healthy Adults [Phase 2]

  Phase 2 trial update for BPZE1 intranasal pertussis vaccine (Prime + Boost) in healthy adults; study completed with results posted in 2023.

• CLINICAL_TRIALS safety_alert · 2022-05-18
  Clinical Trial Update: The Safety of Boostrix Following Routine Immunization of Pregnant Women

  Clinical trial update assessing the safety of Boostrix administered after routine immunization of pregnant women.

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• CLINICAL_TRIALS trial_result · 2020-07-07
  Clinical Trial Update: Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants <2 Months Old in the United States

  A completed clinical trial evaluating maternal immunization with Boostrix to prevent pertussis in infants under 2 months in the United State…

• CLINICAL_TRIALS trial_result · 2020-01-23
  Clinical Trial Update: A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3111 in Healthy Adults [Phase 2]

  Phase 2 trial evaluating safety and immunogenicity of GC3111 in healthy adults for tetanus, diphtheria, and pertussis. Status is unknown.

• CLINICAL_TRIALS trial_result · 2019-07-31
  Clinical Trial Update: A Phase 1/2 Clinical Trial of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine [Phase 1, Phase 2]

  Phase 1/2 clinical trial update for a live intranasal Bordetella pertussis vaccine (GamLPV) investigating protection against whooping cough.

• CLINICAL_TRIALS trial_result · 2017-06-23
  Clinical Trial Update: EUpertstrain 4 Study of Bordetella Pertussis Isolates

  The EUpertstrain 4 study investigating Bordetella pertussis isolates has completed.

• CLINICAL_TRIALS trial_result · 2017-03-29
  Clinical Trial Update: Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children [Phase 3]

  Phase 3 safety study results completed for combination vaccines Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY in child…

• EMA withdrawal · 2014-01-07
  EMA Lapsed: Tritanrix HepB (Diphtheria toxoid;hepatitis B surface antigen;Bordetella pertussis (inactivated);tetanus toxoid) — GlaxoSmithKline Biologicals S.A.

  EMA status shows the Tritanrix HepB vaccine has lapsed and is no longer an active medicinal product in the EU.

• EMA withdrawal · 2013-08-23
  EMA Lapsed: Infanrix Penta (Diphtheria toxoid;tetanus toxoid;Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin);poliovirus (inactivated) (type 1 (Mahoney strain), type 2 (MEF-1 strain), type 3 (Saukett strain));hepatitis B surface antigen) — GlaxoSmithKline Biologicals S.A.

  EMA status indicates Infanrix Penta is lapsed, with the product no longer active in this market.

• EMA withdrawal · 2012-08-16
  EMA Withdrawn: Hexavac (purified diphtheria toxoid;purified tetanus toxoid;purified pertussis toxoid;purified pertussis filamentous haemagglutinin;hepatitis B surface antigen;Inactivated Type 1 Poliovirus (Mahoney);Inactivated Type 3 Poliovirus (Saukett);Haemophilus influenzae type b polysaccharide) — Sanofi Pasteur MSD, SNC

  The EMA has withdrawn Hexavac, a hexavalent combination vaccine, from the market. The decision was taken in 2012 and concerns multiple indic…