A comparison of immunogenicity and safety of indigenously developed liquid (DTwPHB-Hib) pentavalent combination vaccine (Shan 5) with Easyfive (liq) and TritanrixHB + Hiberix (lyo) in Indian infants administered according to the EPI schedule

Human Vaccines

Volumn 5, Issue 6, 2009, Pages 425-429

  Rao, Raman ^k   Dhingra, Mandeep S ^a   Bavdekar, Sandeep ^a   Behera, Narendra ^b   Daga, Subhash R ^c   Dutta, Ashok K ^d   Kundu, Ritabrata ^e   Maiya, Padmanabha ^f   Mishra, Pravakar ^g   Shah, Raju ^h   Shuba, Sankaranarayan ⁱ   Tibrewala, Vinoo ^j   Pandhi, Shaloo ^k   Rajamani, Arul Mani ^k  

^a KEM HOSPITAL   (India)

^b MKCG MEDICAL COLLEGE   (India)

^c BJ Government Medical College and Sassoon General Hospitals   (India)

^d KALAWATI SARAN CHILDREN'S HOSPITAL   (India)

^e INSTITUTE OF CHILD HEALTH   (India)

^f MS Ramaiah Medical Hospital   (India)

^g SVP PG Institute of Pediatrics   (India)

^h Ankur Institute Child Health   (India)

ⁱ SRI RAMACHANDRA UNIVERSITY   (India)

^j BOMBAY HOSPITAL   (India)

^k Clinical Research Division   (India)

more..

Author keywords

Hepatitis B; Hib conjugate; Immunogenicity; India; Pentavalent; Vaccine

Indexed keywords

DIPHTHERIA PERTUSSIS TETANUS HAEMOPHILUS INFLUENZAE TYPE B HEPATITIS B VACCINE; EASYFIVE; HEPATITIS B SURFACE ANTIBODY; IMMUNOGLOBULIN G ANTIBODY; SHAN 5; TRITANRIXHB PLUS HIBERIX; UNCLASSIFIED DRUG;

ANTIBODY BLOOD LEVEL; ANTIBODY TITER; ARTICLE; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CRYING; DOSE RESPONSE; DROWSINESS; DRUG DOSAGE FORM COMPARISON; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FEVER; HUMAN; HYPOTONIC HYPORESPONSIVE EPISODE; IMMUNE RESPONSE; IMMUNOGENICITY; INDIAN; INFANT; INJECTION SITE PAIN; INJECTION SITE SWELLING; IRRITABILITY; LIMB DISEASE; MALE; MOTOR DYSFUNCTION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCLE TONE; PAIN; PATHOLOGICAL CRYING; RANDOMIZED CONTROLLED TRIAL; SEIZURE; SIDE EFFECT; SINGLE BLIND PROCEDURE; SKIN REDNESS;

EID: 70349521818     PISSN: 15548600     EISSN: 15548619     Source Type: Journal    
DOI: 10.4161/hv.5.6.7816     Document Type: Article

References (11)

1. World Health Organization. Global Immunization Data - October 2008. Available at URL: http://www.who.int/immunization/newsroom/ global_immunization_data_october2008.pdf. Accesed on 2008.
2. Country facts file on Maternal, Newborn and Child Health situation in India. Centre for Community Medicine. All India Institute of Medical Sciences New Delhi.
3. Miguel T, Pio L, Crisanta R, Luis R, Marie-Pierre D, Ricardo R, et al. A new DTPw-HBV/hib vaccine is immunogenic and safe when administered according to the EPI (Expanded Programme for Immunization) schedule and following Hepatitis B vaccination at birth. Pan Am J Public Health 2006; 19:179-88.
4. Edwards KM, Decker MD. Challenges for licensure of new diphtheria, tetanus toxoid acellular pertussis (DTaP) combination vaccine. Counterpoint. Pediatr Infect Dis J 1996; 314:1033-7.
5. David E, Helen B. Safety and efficacy of combination vaccine. BMJ 2003; 326:995-6.
6. World Health Organization. WHO position paper on Haemophilus influenzae type b conjugate vaccines. Weekly Epidemiological Record 2006; 81:445-52.
7. Ali SS, Chandrasekhar SR, Singh M, Bansal RK, Sharma DR, Arora D. A multicenter, prospective, open-label, non-comparative study to evaluate the immunogenicity and tolerance of a new, fully liquid pentavalent vaccine (DTwP-HepB-Hib Vaccine). Human Vaccines 2007; 3:116-21.
8. Kanra G, Kara A, Demiralp O, Contorni M, Hilbert AK, Spyr C, et al. Safety and immunogenicity of a new fully liquid DTPw-HepB-Hib combination vaccine in infants. Human Vaccines 2006; 2:155-60.
9. Scheifele DW, Halperin SA, Rubin E, Tapiero B, Guasparini R, Meekison W, et al. Safety and immunogenicity of a pentavalent combination vaccine (Diphtheria, Tetanus, Acellular pertussis, polio and Haemophilus influenza type b conjugate) when administered as a fourth dose at 15 to 18 months of Age. Human Vaccine 2005; 1:180-6.
10. Kohl KS, Walop W, Gidudu J, Ball L, Halperin S, Hammer SJ, et al. The Brighton Collaboration Working Group for swelling at or near injection site. Swelling at or near injection site: case definition and guidelines for collection, analysis and presentation of immunization safety data. Vaccine 2007; 25:5858-74.
11. Marcy SM, Kohl KS, Dagan R, Nalin D, Blum M, Jones MC, et al. The Brighton Collaboration Fever Working Group. Fever as an adverse event following immunization: Case definition and guidelines for data collection, analysis and presentation. Vaccine 2004; 22:551-6.