Infanrix Hexa (diphtheria tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated poliomyelitis, adsorbed conjugated Haemophilus influenzae type b vaccine) / GSK - LARVOL DELTA

A Study on the Safety, Reactogenicity, and Immune Response to the GVGH iNTS-GMMA Vaccine Against Invasive Nontyphoidal Salmonella in Adults, Children, and Infants (clinicaltrials.gov) - P2 | N=183 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

Long-Term Immunogenicity of the altSonflex1-2-3 Shigella vaccine in African children (clinicaltrialsregister.eu) - P2 | N=179 | Sponsor: GlaxoSmithKline Biologicals SA

New P2 trial • Dermatology • Infectious Disease

A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants (clinicaltrials.gov) - P1/2 | N=551 | Completed | Sponsor: GlaxoSmithKline | Phase classification: P1 ➔ P1/2

Phase classification

PRE-BOOSTER IMMUNE RESPONSE TO HEXAVALENT VACCINES IN UK INFANTS AGED 18 MONTHS (ESPID 2026) - "Method UK-based infants receiving a three-dose Infanrix hexa (Hex-I) or Vaxelis (Hex-V) hexavalent vaccine schedule at 2-3-4 months were recruited at 12-months of age with no Hib/MenC given. Significantly higher antibody titres were observed against pertussis filamentous hemagglutinin and polio type I in Hex-I-primed compared to Hex-V-primed infants. Conclusions/Learning Points These data show persistence of anti-PRP antibodies at 14-months post-prime vaccinations for both hexavalent vaccines; however, a higher proportion of Hex-I-primed infants had anti-PRP levels below the protective threshold."

Infectious Disease • Influenza

A RANDOMISED CONTROL TRIAL EVALUATING IMMUNOGENICITY FOLLOWING INTERCHANGEABLE USE OF TWO HEXAVALENT VACCINES FOR BOOSTER IMMUNISATION: THE 6-IN-1 PART 2 STUDY (ESPID 2026) - "We investigated the interchangeability of Infanrix hexa (HexI) or Vaxelis (HexV) as hexavalent vaccines used in primary and booster immunisation. Conclusions/Learning Points High proportions of infants with anti-PRP concentrations at/above the 1.0µg/mL protection threshold were observed across all groups. Seroprotection against Hib at 1-month post-booster in heterologous hexavalent booster schedules were non-inferior to homologous schedules, supporting interchangeability of HexI and HexV boosters."

Clinical • Infectious Disease

PARENTAL MOTIVATIONS AND EXPERIENCES IN THE 6-IN-1 PART 2 VACCINE TRIAL STUDY (ESPID 2026) - "Background The 6-in-1 part 2 study evaluated the interchangeability of Infanrix Hexa and Vaxelis, and giving the second MMR dose at 18 months in the context of the UK infant immunisation schedule. Conclusions/Learning Points Offering a variety of recruitment methods is likely to be important and should be maintained to facilitate participation. Understanding parent motivations - child safety, altruism, and direct benefit - can help optimise the design of trials and trial materials to increase recruitment and trial completion."

Infectious Disease • Novel Coronavirus Disease • Varicella Zoster

An Open Label, Single Arm, Phase I/II Clinical Study of Autologous CD4+ T-Cells Edited Ex-Vivo at the CD40LG Locus by CRISPR/Cas9 and IDLV-based vector in Patients with X-linked Hyper IgM Syndrome Type 1 (HIGM1) (clinicaltrialsregister.eu) - P1/2 | N=4 | Not yet recruiting | Sponsor: Fondazione Telethon Ets, San Raffaele Hospital

New P1/2 trial • Immunology • Primary Immunodeficiency

A Study on the Safety, Reactogenicity, and Immune Response to the GVGH iNTS-GMMA Vaccine Against Invasive Nontyphoidal Salmonella in Adults, Children, and Infants (clinicaltrials.gov) - P2 | N=215 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | N=516 ➔ 215 | Trial completion date: Apr 2026 ➔ Sep 2026 | Trial primary completion date: Apr 2026 ➔ Sep 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease

Multiparametric analysis of vaccine-induced B and T cell responses for optimal evaluation of memory immune responses to Bordetella pertussis in children. (PubMed, Vaccine) - "Group III (n = 42) received aPV (Infanrix-hexa) in infancy and one aPV booster...Finally, Th1-type CD4+ T cells and FHA- and PRN-specific humoral and/or Bm responses were detected in group III. A combination of humoral and cellular markers of immunity to B. pertussis thus offers a more comprehensive assessment of immunity compared to serology alone and reveals that almost all recipients of a recent aP booster have several markers of immune memory."

Journal • Cough • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus • CD4 • IFNG • TNFA

IM-101_MG_2.1: A Phase 1b/2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of IM-101 in Adult Participants with Generalized Myasthenia Gravis and Ocular Myasthenia Gravis (clinicaltrialsregister.eu) - P1/2 | N=83 | Not yet recruiting | Sponsor: Immunabs Inc.

New P1/2 trial • CNS Disorders • Myasthenia Gravis

Immunogenicity of two versus three doses of hepatitis B vaccine when administered to children aged 2-18 months: a randomized clinical trial. (PubMed, J Infect Dis) - "The anamnestic response three years after two- (2, 12 months) and three-dose (2, 4, 18 months) hepatitis B vaccination schedules was similar. The heterologous two-dose schedule was more immunogenic and less reactogenic than the homologous two-dose schedule."

Clinical • Journal • Hepatitis B • Infectious Disease • Inflammation

Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (clinicaltrials.gov) - P1/2 | N=750 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Meningococcal Infections • Pediatrics

Immunogenicity of 2 Versus 3 Doses of Combined Hepatitis B Vaccines in 2-18 Months Old Children (clinicaltrials.gov) - P4 | N=431 | Completed | Sponsor: Laval University | Recruiting ➔ Completed | Phase classification: P3 ➔ P4

Phase classification • Trial completion • Hepatitis B • Infectious Disease • Inflammation

H06_04TP: Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children (clinicaltrials.gov) - P2 | N=528 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P2 trial

A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants (clinicaltrials.gov) - P2 | N=200 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion

A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants (clinicaltrials.gov) - P1 | N=551 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion

BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies (clinicaltrials.gov) - P3 | N=6000 | Recruiting | Sponsor: Pfizer

New P3 trial

A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants (clinicaltrials.gov) - P2 | N=200 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed

PRELIMINARY ANALYSIS OF PRE-BOOSTER IMMUNE RESPONSE TO HEXAVALENT VACCINES FOLLOWING THREE-DOSE PRIME VACCINATION IN PRETERM INFANTS (ESPID 2025) - "Methods UK-based infants receiving a three-dose Infanrix hexa (Hex-I) or Vaxelis (Hex-V) hexavalent vaccine schedule at 2-3-4 months were recruited at 12-months and not given Hib/MenC. Sample analysis is ongoing; more samples expected by May 2025. Conclusions/Learning Points These preliminary data suggest that infants born preterm have lower anti-PRP antibodies at 18-months than term infants and could be at increased risk of Hib infection prior to booster vaccination."

Prematurity • Hepatitis B • Infectious Disease • Influenza • Pertussis

Bifidobacteria support optimal infant vaccine responses. (PubMed, Nature) - "Exposure to direct neonatal but not intrapartum antibiotics was associated with significantly lower antibody titres against various polysaccharides in the 13-valent pneumococcal conjugate vaccine and the Haemophilus influenzae type b polyribosylribitol phosphate and diphtheria toxoid antigens in the combined 6-in-1 Infanrix Hexa vaccine at 7 months of age...In preclinical models, responses to the 13-valent pneumococcal conjugate vaccine were strongly dependent on an intact microbiota but could be restored in germ-free mice by administering a consortium of Bifidobacterium species or a probiotic already widely used in neonatal units. Our data suggest that microbiota-targeted interventions could mitigate the detrimental effects of early-life antibiotics on vaccine immunogenicity."

Journal • Infectious Disease • Influenza • Pneumococcal Infections • Respiratory Diseases

Acellular Pertussis Vaccine Given in the Week After Birth Does Not Impair Antibody Responses to Later Childhood Doses. (PubMed, Pediatr Infect Dis J) - "A birth dose of acellular pertussis vaccine does not impair antibody responses to booster doses of pertussis vaccines and may be an alternative for protection against early infant pertussis when pertussis booster has not been administered during pregnancy."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Pertussis • Respiratory Diseases • Tetanus

A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants (clinicaltrials.gov) - P1 | N=552 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | Phase classification: P1/2 ➔ P1

Enrollment closed • Phase classification

A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open

Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (clinicaltrials.gov) - P1/2 | N=750 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Meningococcal Infections • Pediatrics

A study on the immunogenicity and safety of a multicomponent Shigella vaccine in preventing shigellosis in infants (clinicaltrialsregister.eu) - P2 | N=200 | Sponsor: GlaxoSmithKline Biologicals

New P2 trial • Dermatology • Infectious Disease