Immunogenicity and Safety of <i>H influenzae</i> Type b–<i>N meningitidis</i> C/Y Conjugate Vaccine in Infants

Bryant, Kristina; Marshall, Gary S.; Marchant, Colin D.; Pavia-Ruiz, Noris; Nolan, Terry; Rinderknecht, Stephen; Blatter, Mark M.; Aris, Emmanuel; Lestrate, Pascal; Boutriau, Dominique; Friedland, Leonard R.; Miller, Jacqueline M.

doi:10.1542/peds.2009-2992

Cited by 27 publications

(67 citation statements)

References 24 publications

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“…We cannot exclude immune interference between the administered antigens, impacting on the pertussis responses. While there are differences between the responses observed here and previously published studies [7,23], it is worth noting that the previously published data assessed the pertussis responses following the first three doses, whereas the current publication evaluated the response to the fourth dose. It is possible that there is an impact of immune interference of the first three doses of HibMenCY-TT on the development of immune memory to a fourth dose of pertussis vaccine.…”

Section: Discussioncontrasting

confidence: 67%

“…However, the highest IMD burden continues to be observed in infants aged <1 year (approximately 5.38 cases per 100,000 population, 1998-2007, US data), with around one-half caused by serogroup B [2]. The meningococcal serogroup C and Y vaccine combined with Haemophilus influenzae type b conjugate vaccine (HibMenCY-TT, MenHibrix TM , GlaxoSmithKline Vaccines) targets three major causes of meningitis [7][8][9][10][11][12][13][14] and is approved in the US for use as a four-dose series for infants. HibMenCY-TT is recommended by the Advisory Committee on Immunization Practices (ACIP) for use in infants and children at increased risk for IMD such as those with complement deficiencies or asplenia including sickle cell disease, and may be used as an alternative for routine vaccination against Hib [15].…”

Section: Introductionmentioning

confidence: 99%

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Immunogenicity and reactogenicity of Infanrix™ when co-administered with meningococcal MenACWY-TT conjugate vaccine in toddlers primed with MenHibrix™ and Pediarix™

Leonardi

Latiolais²,

Sarpong

et al. 2015

Vaccine

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Section: Discussioncontrasting

confidence: 67%

Section: Introductionmentioning

confidence: 99%

Immunogenicity and reactogenicity of Infanrix™ when co-administered with meningococcal MenACWY-TT conjugate vaccine in toddlers primed with MenHibrix™ and Pediarix™

Leonardi

Latiolais²,

Sarpong

et al. 2015

Vaccine

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“…27 Moreover, other studies have shown comparable immune responses to PCV7 and the meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine in term infants compared with preterm infants who were permitted palivizumab prophylaxis. 6,28 In future studies, stratifying the results of our study according to baseline medical conditions may provide further insight into vaccination in this vulnerable population. Epidemiologic studies in preterm infants are also needed to confirm that PCV13 is effective in this population.…”

Section: E880mentioning

confidence: 99%

13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Preterm Versus Term Infants

et al. 2015

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OBJECTIVES: This study evaluated the immune response and safety profile of 13-valent pneumococcal conjugate vaccine (PCV13) in preterm infants compared with term infants.METHODS: This Phase IV, open-label, 2-arm, multicenter, parallel-group study enrolled 200 healthy infants (preterm, n = 100; term, n = 100) aged 42 to 98 days. All subjects received PCV13 at ages 2, 3, 4 (infant series), and 12 (toddler dose [TD]) months, together with routine vaccines (diphtheriatetanus-acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b vaccine and meningococcal group C conjugate vaccine).RESULTS: Most subjects achieved an anticapsular immunoglobulin G (IgG) antibody concentration $0.35 mg/mL for all serotypes: .85% after the infant series (except preterm infants for serotypes 5, 6A, and 6B) and .97% after TD (except for serotype 3). Preterm infants had overall lower IgG geometric mean concentrations compared with term infants; however, geometric mean fold increases after TD were similar for all serotypes. Opsonophagocytic activity results were consistent with IgG results and titers increased after TD in both groups for all serotypes, including serotype 3. PCV13 was generally well tolerated, with similar safety profiles in all preterm subgroups.CONCLUSIONS: Immune responses were lower in preterm infants than in term infants. However, the majority of subjects in both groups achieved both pneumococcal serotype-specific IgG antibody levels after the infant series that exceeded the World Health Organization-established threshold of protection and functional antibody responses. Responses were uniformly higher after TD, reinforcing the importance of a timely booster dose. PCV13 was well tolerated regardless of gestational age.

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“…There have been six published phase II and III clinical trials investigating the safety and immunogenicity of HibMenCY-TT (Table 1) [31–37]. The initial phase II/dose-finding comparative studies were performed in between 2003 and 2004 in Australia [31] and Belgium and Germany [32].…”

Section: Clinical Trial Datamentioning

confidence: 99%

A Licensed Combined Haemophilus influenzae Type b-Serogroups C and Y Meningococcal Conjugate Vaccine

2013

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The highest incidence of meningococcal disease occurs in infants younger than 1 year of age. However, in the US, prior to June 2012, there was no meningococcal vaccine licensed for use in this age group. In the US, where both serogroups C and Y contribute substantially to the overall epidemiology of invasive meningococcal disease, a vaccine combining these capsular polysaccharides was developed. We review the newly licensed HibMenCY-TT (MenHibrix™, GlaxoSmithKline Biologicals, Rixensart, Belgium), a novel vaccine containing Haemophilus influenzae type b (Hib) and serogroups C and Y Neisseria meningitidis conjugated to tetanus toxoid. We describe the vaccine, summarize the clinical trial data, and describe the patient populations recommended to receive HibMenCY-TT as their primary vaccination against Hib. Phase II and III clinical trials found HibMenCY-TT to be well tolerated, safe, and immunogenic when administered at 2, 4, 6, and 12–15 months of age for primary vaccination against both Hib and serogroups C and Y meningococcal disease. In October 2012, the Advisory Committee on Immunisation Practice in the US recommended HibMenCY-TT vaccination for infants at increased risk of meningococcal disease. HibMenCY-TT may be given concomitantly with other routine infant vaccines. It induces antibodies against Hib as well as bactericidal activity against meningococcal serogroup C and Y without increasing the number of injections required. As meningococcal disease epidemiology is dynamic, global surveillance remains essential. In the future, other countries may also benefit from the addition of HibMenCY-TT into their vaccine armamentarium against meningococcal disease.

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Immunogenicity and Safety of H influenzae Type b–N meningitidis C/Y Conjugate Vaccine in Infants

Abstract: The HibMenCY was immunogenic against MenC and MenY and induced anti-polyribosylribitol phosphate antibody levels noninferior to those of licensed Hib conjugate vaccine. The safety profile of the HibMenCY was clinically acceptable and comparable to Hib conjugate vaccine.

Cited by 27 publications

References 24 publications

Immunogenicity and reactogenicity of Infanrix™ when co-administered with meningococcal MenACWY-TT conjugate vaccine in toddlers primed with MenHibrix™ and Pediarix™

Immunogenicity and reactogenicity of Infanrix™ when co-administered with meningococcal MenACWY-TT conjugate vaccine in toddlers primed with MenHibrix™ and Pediarix™

13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Preterm Versus Term Infants

A Licensed Combined Haemophilus influenzae Type b-Serogroups C and Y Meningococcal Conjugate Vaccine

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